CLINICAL RESEARCH
EXECUTIVE DIRECTOR, STATISTICAL PROGRAMMING WFH $230-$260K, 10% BONUS PLUS FULL AND COMPREHENSIVE BENEFITS PACKAGE
Our client in industry is
experiencing tremendous growth and as a result this newly created position has
become available. We are searching for an experienced Statistical Programming
leader to manage a team of like minded Quality driven professionals. This
strategic opportunity will lead and manage a group of Statistical Programmers
working on phase I-IV clinical trials in most Therapeutic categories. As
Executive Director, you will manage teams, projects, and client relations
simultaneously.
Bring your technical expertise (Preparing SDTM data
mapping specification, ADaM dataset specifications, data reviewer's guides and
define .xml documents; perform QC review of documents; generate statistical
tables, listings and graphs in accordance with Statistical Analysis plans and
formats; ability to perform independent SAS programming validation of datasets;
contribute to continuous improvement of clinical standards and SOP's; design and
implement SAS macros) combined with your ability to instill a code of conduct to
a group of highly educated Statistical Programmers promoting corporate culture
and values is key to the success of this role.
Planning and organizing site specific events and
activities and working with functional group leaders will be part of your
mandate for this exciting high level career opportunity. Overseeing the
day-to-day operational effectiveness of the office including liaising with all
departments in order to achieve an environment of operational excellence, will
be part of the management responsibilities.
Lead deliverable tasks in a timely, accurate and
efficient manner to ensure quality and productivity leading study teams by
participating in resource planning and managing timelines of project
deliverables. Provide training, mentorship and technical guidance to the
Statistical Programmers.
A Master's
degree in Statistics, Biostatistics, Bioinformatics, Computer Science,
Mathematics or other relevant field is required with at least 10 years of
relevant industry experience using SAS in Clinical Trial analysis and reporting
OR a
PhD degree or equivalent in statistical science, Mathematical
analysis or related plus 5 years of relevant experience leading teams.
Bring your In-depth knowledge of clinical trial data
processing and manipulation, hands on statistical programming and analysis and
we can arrange for a meeting of the minds with our client!
Salary: $230-$260K, 10% bonus, Long Term Incentive bonus, and a full and comprehensive benefits package.
Please call me directly 416 225-6386 and please send your updated Resumes
for consideration. Thank you, Cris Murray,
jedgar@sympatico.ca
SENIOR DIRECTOR EXECUTIVE DIRECTOR BIOMETRICS, BIOSTATISTICS CANADA OR USA WFH BASED $260K- $290K, 401K, BONUS, OPTIONS AND COMPREHENSIVE BENEFITS AND HEALTH CARE PACKAGE
Our growing, successful quality client is seeking nd
Executia
Senior Director ave Director of Biostatistics to manage the daily activities of the
Biostatistics staff to ensure everyone is well-trained on SOP's and to promote
efficiency, quality, and timelines in all project deliverables.
Bring your technical expertise, positive personality and business savvy nature
to the table and we have found you a match. Our client is looking for a
dedicated communicator, senior leader who is ready for their next challenge. You
will lead, guide, build and maintain key client relationships; be responsible
for departmental growth and development, including budgeting, forecasting and
proposal development. Mentoring and leading Biostatistics departments for all
clinical phase 1-4 projects will be the main focus of this career opportunity.
Key Accountabilities:
Provide leadership and expertise in resolving
complex operational and technical problems in support of division/company
objectives and projects, or as a resource to others. Maintain expertise in
industry norms, trends across biometrics and regulatory requirements.
Provide supervision to ongoing projects by applying
management skills, regulatory standards and requirements, and quality
management to ensure quality and timely deliverables.
Build and maintain relationships with assigned
clients to ensure biometrics services are well represented and that
communication with the client and the functional teams are clear.
Represent biometrics for the company in external
business development, regulatory or industry consortiums.
Represent biometrics functional service group in
external and internal audits, as well as qualification/maintenance audits
for vendors contracted.
Monitor and assess the progress status of ongoing
projects. Ensure high quality standards, on time delivery within budget for
all stages of the clinical trials – from the trial design, protocol
development, statistical analysis planning and execution, to the writing of
statistical sections of the Clinical Study Reports or the generation of
publications of trial results.
Support cross-functional biometrics process
development, making multi-disciplinary teams more effective by utilizing the
strengths of each biometrics functional team.
Provide leadership and expertise in day-to-day
statistical operations and development of statistical methodologies to solve
practical statistical problems.
Serve as a principal level biostatistician, working
effectively with interdisciplinary teams to contribute to drug development
at the study and drug compound levels. Provide statistical consultation to
trial medical/clinical personnel when required.
Participate in development of study concepts and
study protocols.
Lead statistical and programming teams on assigned
projects. Plan and manage resources, timelines, and quality of statistical
and programming deliverables.
Perform planned, ad hoc, and/or exploratory
statistical analyses.
Write Statistical Analysis Plans, Statistical
Reports, and statistical methodologies sections of Clinical Study
Reports, publications, abstracts, posters, presentations, etc. Review
statistical documents generated by others.
Perform independent validation of statistical
results generated by others and perform third level Quality Control review
on statistical and programming deliverables before they are released to the
clients.
Interact with regulatory agencies and support
client in New Drug Applications/Biologic License Applications. This includes
participating as a statistical liaison to the regulatory agency on behalf of
the client and ensuring documentation, statistical results, and study
datasets meet the regulatory agency’s requirements and expectations (e.g.,
CDISC).
Mentor and supervise direct and indirect
subordinates. Perform semi-annual and annual performance reviews and prepare
developmental plans for direct subordinates and indirect subordinates, where
appropriate, through contributing to the performance evaluation process.
Plan and manage resourcing plans by working with
the Project Management group in forecasting resource needs relative to the
roles of the personnel. Proactively and continually update the plan with
changes to demand and identify/solution resourcing gaps or overage.
Participate in recruiting and staffing for
responsible functional area, as well as coaching, mentoring, and developing
staff members.
Contribute to the company’s management team
function and activities.
Qualifications and Experience:
A Ph.D. degree in statistical science, mathematical
analysis, or related fields with at least 8 years of relevant experience or
a Master’s degree in these fields with at least 10 years of relevant
experience.
Minimum of 3 years managing people, with
demonstrated exceptional ability and performance.
Significant contribution, and/or
outstanding/sustained performance may be used in lieu of the requirement on
the number of years of relevant experience.
These high level positions reports into a senior executive who reports into the
President. Work in tandem with a strong team to reach new heights and have the
autonomy to act as a business owner with an entrepreneurial spirit.
Salary: $260-$290K, 401K, bonus, Options, and full benefits package. WFH career opportunity. Please call Cris Murray 416 225-6386, VP Recruitment, J. Edgar and Associates Inc. to apply to this exciting career opportunity. Please send your CV to me directly: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.
Please call me directly 416 225-6386 and please send your updated Resumes
for consideration. Thank you, Cris Murray,
jedgar@sympatico.ca
PRINCIPAL BIOSTATISTICIAN/STATISTICIAN - MEDICAL DEVICES - LEADING TECHNOLOGY - REMOTE USA
This is an exciting opportunity for a
Statistician or Biostatistician to work with a world leading Medical Device
innovator currently in development of a new technology that walth
oill change heutcomes and ensure longevity in a leading disease category.
We an experienced
Statistician to deliver clinical project activities by providing
efficient clinical trial design and sample size through Clinical Study Synopsis
and the Clinical Investigation Plan (CIP). This will include the development of
simulation programs to assess trial operating characteristics as they are
required.
Responsibilities:
Development and input of effective data collection
and derivation strategies. Thorough randomization plan and list. Accurate,
clear, and thorough statistical analysis plan (SAP)development
with the most appropriate methodology and data presentation. Support
blind data review process and un-blinding process. Provide
are currently seekingprogramming
instructions to statistical programmers and check and approve statistical
programming deliverables. Communicate, discuss, and interpret (top line) data
and statistical results, including co-development of the clinical study report
(CSR). Appropriate management and surveillance of external suppliers for
outsourced statistical services. Collaborate with Manufacturing on process
improvements including statistical process control (SPC) and statistical quality
control (SQC). Develop and validate statistical models and simulations AND
provide ad hoc statistical support for R&D to aid new product development.
Perform design of experiments (DOE) to identify optimal parameter settings.
Contribute to the development of protocols for test method validation, process
validation, and design V&V activities with a focus on sample size justification
and data analysis. Write reports which describe and interpret the experimental
design of studies, methods of data analysis, and relevant results. Develop and
implement procedures and best practice documents to standardize valid
statistical approaches for common business needs. Provide basic statistical
training to small groups of engineers and scientists during project work. Review
new statistical methods for application to existing processes. Ensure that all
activities under responsibility are properly documented (traceability of
changes, data specifications, analysis validation) according to internal
procedures. Contribute to project management plans and ensure that deadlines are
met. Develop, apply and maintain computer programs for data analysis, e.g., SAS
and R. Lead and participate in process and infrastructure projects while acting
as an internal subject matter expert related to statistical activities.
Encourage and maintain quality in all activities and follow the internal quality
system. Collaborate effectively with Statistics & Data Management internal and
external partners in all activities where statistics is needed. Communicate
routine and complex statistical concepts and results to non-statistical internal
and external colleagues in a clear, concise, and articulate manner. Apply
personal experience, research, input from colleagues, and critical thinking to
challenge data analysis results originating from other individuals or yourself.
Requirements: We are looking for a self starter
with the ability to provide statistical expertise to a technical group of
innovators seeking to commercialize a major medical device development. You must
be able to scale up and scale down workloads based on project needs. Experience
leading cross-functional teams to reach required objectives is important in this
role. As Principal Statistician, you will be recognized as an expert throughout
the organization in multiple areas. Your ability to implement
improvements both in statistics and other areas of the company including
developing processes will be beneficial in this role.
We are seeking demonstrable advanced experiences in clinical development in the
pharmaceutical, CRO, or medical device industry, in the development and
implementation of advanced methods such as adaptive design, Bayesian statistics,
and missing data analysis. Basic knowledge of CDISC, SDTM and ADaM. Strong
skills in statistical software such as SAS, R. Master degree in
Statistics/Biostatistics with 14 combined years of experience in a life science
industry in clinical or product development either in pharmaceutical, medical
device or CRO.12 years of relevant experience with Ph.D.
Location - Remote USA
Please send your CV directly to me for
consideration:
SENIOR
PHARMACOKINETIC/PD SCIENTIST - TORONTO - GREAT FIRM -
$150K
- $190K PLUS BONUS -
REMOTE AND HQ SITE WORK
Accountabilities:
Conduct PK/PD data analysis using non-compartmental analysis. You may also
provide support in the conduct of advanced population PK/PD modeling and
simulation and/or disease modeling using software such as WinNonlin, NONMEM,
S-PLUS, Clinical Trial Simulator, etc. Apply and/or provide strategic direction
and vision on PK/PD data analysis to support clinical trial designs, compound
development plans, and regulatory submissions. Generate predictive simulations
and provides input into trial protocol development. Provide mentorship and
oversight to PK Scientists Level I and II. Write clinical trial Statistical
Analysis Plans including PK/PD analysis components or write separate PK/PD
Analysis Plans. Author and/or review PK/PD related documents or reports such as
PK Study Reports, ensuring appropriate and accurate interpretation of PK study
endpoints. Contribute to the clinical pharmacology sections of relevant
documents, such as clinical study protocols, clinical study reports,
investigator's brochures, briefing documents, and IND/NDA submissions. May work
with regulatory affairs personnel to provide PK/PD data in support of regulatory
communications and presentations as needed. May represent the company on PK/PD
issues at appropriate scientific meetings, for regulatory issues, and with
clinical trial clients. Participate in the development and maintenance of, and
adhere to divisional Standard Operating Procedures (SOPs) and guidelines, and to
therapeutic area specific standards and conventions. Keep current with the
general requirements or guidelines issued by the pharmaceutical drug trial
regulators and ICH. Plan and carry out professional development.
Requirements:
Advanced degree, Ph.D. or M.Sc. in Clinical Pharmacology (including
Pharmacokinetics, Pharmacodynamics), Pharmacy, Biopharmaceutics or related
field. At least five-six years' experience as a PK Scientist in the
pharmaceutical clinical trial environment. Experience in multiple therapeutic
areas and Phase I through IV clinical trials an asset. Proficient in using
WinNonlin, or other relevant pharmacokinetic software for non-compartmental
analysis, PK/PD analysis, and modeling. Familiarity with SAS is preferred (or
willing to learn and master SAS skills). Excellent understanding of clinical
trials and common clinical trial statistical analysis methods. Skilled in
scientific writing and data interpretation. Demonstrated ability to understand
PK results; able to communicate effectively, orally and in writing. Demonstrated
ability for logical thinking, vision, and creativity necessary to function
effectively with a large degree of independence and little supervision.
Experience with client relationship management. Ability to multi-task, manage
multiple projects with competing and aggressive timelines. Excellent
interpersonal and teamwork skills; detail-oriented, customer- and
quality-focused. Well organized and able to work independently. Strong
understanding of fundamental PK and statistical principles.
Salary
- $120-150K Bonus - 10% -
Benefits - Thorough and Full
MANAGER OF PHARMACOVIGILANCE OR SENIOR PV/DS CLINICAL TRIAL ASSOCIATE - TORONTO - $150K - $200K PLUS BONUS AND BENEFITS
We are currently seeking an experienced Clinical Drug
Safety expert to fulfil the position of Manager of Pharmacovigilance or Senior
Clinical Drug Safety Associate to assist a highly successful and growing firm in
the development and optimization of their PV and DS program and services
capabilities.
RESPONSIBILITIES: Assume a leader/mentorship role in the training of safety associates for clinical safety monitoring activities, ensuring compliance with PV processes and procedures as outlined in study level safety plans. Manage DS projects including the study protocol, SMP, Case Report Forms, Investigator’s Brochure, etc. Perform PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines. Provide support to case processing of SAEs and/or pregnancy reports from clients’ ongoing drug clinical trials in a timely manner, including case triage, data entry, narrative writing, and quality review of cases processed by other team members. Entering case safety data into the safety database and generating queries for any critical or missing information. Write patient narratives for ongoing PV and/or medical writing projects; includes review of patient data such as demographic, medical history, concomitant medication, and adverse event (AE) data in order to write a narrative that is up-to-date, complete and concise. Interacting with the Lead Data Manager to post queries to clinical database, where applicable, or directly with clinical study sites to obtain the missing case information. Performing QC review of data in the safety database entered by another Safety Associate. Interact with the internal Medical Monitor to produce high quality case narratives and regulatory report forms that conform to internal SOPs/standards and regulatory requirements. Participate in the design of SAE report forms for the capturing of safety data in clinical trials. Provide operational support to study start-up PV activities, including authoring or peer review of SMPs and related attachments and forms. Participate in UAT including script development and testing, as applicable, and maintain validation documentation in accordance with governing documents. Generate safety data listings or reports from Argus for assigned clients for periodic and ad hoc reporting. Perform reconciliation activities to ensure consistency of safety data between clinical and safety databases. Ensure all safety-related documentation for client projects is properly filed (e.g., in the Argus Safety System and in the study Trial Master File [TMF]). Ensure compliance with all applicable regulations and timelines for safety case processing and reporting. Contribute to the preparation and review of additional regulatory reporting documents (e.g., IND/DSUR/Annual Reports), or other documents, as necessary. Act as a training resource to staff on case processing and the use of the Argus Safety System and associated case processing workflows. May provide technical support for the Argus Safety System, including assisting with safety database configurations for new and existing clients. Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
Qualifications: BSc. to Pharm D with at least 4 years of experience in Clinical
stage PV/DS and/or Post marketing Phase IV PV/DS responsibilities. Team
Management, leadership/mentorship and Training other Associates are all strong
assets for these positions.
Salary: $100-140K+ 10% Bonus + Full benefits - Toronto or Remote
CLINICAL
PROJECT MANAGER - CANADA/USA REMOTE AND GTA BASED
We are currently seeking a Clinical Project Manager to drive continued success
in a growing and award winning firm.
Key Responsibilities:
The Clinical Project Manager is responsible for defining project scopes,
planning, directing, controlling project activities, managing resources and
budgets, as well as project team performance of cross-functional teams engaged
in clinical research and development activities. This position will work closely
with research partners as a project main point of contact and liaison. These
activities may include but are not limited to managing projects with activities
focused on clinical operations, data management, statistics, medical writing,
subject randomization and drug supply management (IWRS), administration of data
monitoring and adjudication committees, as well as preparing drug submissions to
regulatory agencies.
When required, the incumbent may assist the organization in responding to and
preparing for Request for Information and Request for Proposals, and
subsequently defining work scopes and budgets, and working with senior Business
Operations leaders to perform contract administration activities.
When required, the incumbent may perform clinical trial planning, management,
and site monitoring from the initiation of a trial to its closure.
Accountabilities: Integrate information to define work scopes and determine
resources based on estimate budgets, develop and manage cross-functional project
work plans including resource requirements and utilization, budgets, quality
deliverables and timelines. Manage all project management aspects of assigned
Phase I -IV clinical trials and in accordance to ICH guidelines, FDA, Health
Canada, EMA, and other applicable regulatory and legal requirements. Primary
point-of-contact for clinical trial sponsors to ensure the timely initiation and
completion of clinical projects. Lead cross-functional project teams. Manage the
planning, implementation, conduct and reporting of assigned projects within the
established timelines and budgets, and with the quality and requirements
necessary for regulatory approvals. Coordinate activities between our client and
trial sponsors, and with various supporting groups or third party vendors (e.g.,
central lab and other specialty labs) to ensure that all contractual obligations
are met. Proactively track and manage the financial status against budget and
reconcile expenses across sub-streams of activities. Proactively track and
manage project tasks against timelines and hours spent/budgets, alert management
when there are risks of having major deviations. Prepare project status reports
and maintain accurate and current details. Present project status to internal
and external stakeholders. Function as meeting facilitator for the meetings
involving various internal and external participants.
May provide support in Clinical Operations as required, such as the following:
- Assist in the development of study-specific training materials.
- Manage the process of setting up and maintaining the Trial Master File.
- Review/compile documentation for qualification of clinical sites. Support
review of that documentation to ensure that those clinical sites comply with
ICH-GCP and relevant local regulations.
- Assist with the preparation and negotiation of contracts with vendors and
investigational sites.
Qualifications and Experience:
B.Sc. or M.Sc. in life sciences or health related field.
Minimum of 5 years’ clinical research experience within a CRO or third part
research setting. Experienced as a clinical trial monitor, initiating,
monitoring, and closing out clinical trials will be desirable for Clinical
Operations support tasks. Demonstrated understanding of cross-functional
processes including clinical operations, statistics, data management, subject
randomization and drug supply management, data monitoring and adjudication
committees, regulatory affairs, and medical writing. Knowledge and understanding
of ICH guidelines, FDA, Health Canada, and EMA regulations. French fluency is an
asset.
Salary: $90-110K plus 10% bonus and comprehensive Health care benefits.
ASSOCIATE AND SENIOR DIRECTOR CLINICAL DEVELOPMENT AND CLINICAL OPERATIONS, CANADA OR USA, REMOTE CRO $$
We are currently seeking two (2) committed,
skilled, and customer-focused professionals to join an award winning team as
Clinical Operations Leaders to develop and lead the Clinical Operations teams in
a highly successful, full service, Clinical Research Organization specializing
in every Therapeutic category from Phase I-IV. Bring your superior communication
skills, quality deliverables, stellar customer service, and flexibility in
meeting clients needs, and we have a dynamic career opportunity awaiting your
exploration!
The Clinical Operations Leads serve as the clinical
functional leads, accountable for the site management/clinical monitoring
delivery of assigned tasks and projects as per scope. Will provide clear
oversight and coordination of working across regions to ensure clinical project
and site deliverables are met. Bring your leadership, mentoring, and technical
support to the Clinical Operations team to ensure quality deliverables and
achievement of milestones and financial goals. These high-profile roles will be
responsible for tracking study progress and assessing compliance of the conduct
of clinical trials with regulatory requirements, the clinical study protocol,
study-specific plans, and Standard Operating Procedures.
In these customer facing roles, you will interact with
Study Sponsors, Investigational sites, vendors and other functional departments
related to site management and clinical monitoring activities to ensure timely
and high-quality deliverables at all times. Ensure quality visibility of its
progress through CTMS/eTMF and/or tracking tools. Review study scope of work,
budget and protocol content and ensure the Clinical Operations team are aware of
the parameters. Ensure alignment of clinical activities to budget, including
identification of out-of-scope activities. Escalate to Project Managers any
clinical/site management deliverables (timeline, quality, and budget) at risk,
and any activities or requests which are out of contracted scope.
Develop, train, mentor, and guide clinical operations
team on protocol specific plans, guidelines and timelines, with support from
Clinical Operations Oversight, Project Management, Medical Monitoring, and
Sponsors, to foster a team culture that supports the Clinical Operations team
and results in staff retention. Coach and Mentor Clinical Operations Leads
regarding functional clinical delivery, evaluation of project risks, and
action-oriented implementation. Set priorities for the teams to complete and
manage on a regional and site level. Participate in scheduled Study Management
Team meetings for assigned projects, provide status updates and are accountable
for deliverables. Organize and Lead CRA team meetings to provide study updates
and perform training as needed. Author the Monitoring Plan and accountable for
the Clinical Operations teams (scheduling and report submission/finalization) to
ensure compliance with the Monitoring Plan and understand the monitoring
strategy by providing technical expertise. Liaise across various clinical
stakeholders to compile reports to track progress and performance metrics.
Act as point of contact for clinical site monitoring
and Investigator site questions/issue escalation. Perform site management,
review report progress status of the investigational sites. Communicate directly
with sites to provide direction, assess performance, and propose alternatives to
enhance performance of patient enrollment and data submission. Issue periodic
clinical trial Newsletters when required.
May
conduct co-monitoring/preceptor oversight visits with CRA’s to evaluate staff’s
ability and performance level. May perform Pre-Study, Site Initiation, Interim
Monitoring/Remote, and or Closeout Visits as required.
Lead site feasibility and selection process. Support
review of the documentation (review informed consent forms) to ensure clinical
site comply with ICH-GCP and relevant regulations. Assist with negotiation of
sites, contracts/budgets and prepare payments for Vendors/investigational sites.
Assist with Preparation and submission of regulatory documents to regulatory
agencies, authorities, IRBs and Research Ethics Committees. Collaborate with
functional teams including Medical Monitoring, Pharmacovigilance, and Quality
Assurance to ensure site compliance. Prepare, maintain and complete training on
study specific sponsor SOP’s. May participate in Business Development activities
including strategy, budget input and proposal development.
Equipment/Software:
Microsoft Software (Word, Excel, PowerPoint, Project, Outlook, Calendar,
Contacts, and Tasks). Knowledge of database systems, including Oracle InForm,
MediData Rave, DFdiscover and other Electronic Capture systems. Flex Database
Trial Master File and Clinical Trial Management System.
Qualifications include:
Minimum BSc in life sciences or related field, MSc and/or MBA preferred. At
least 6 years of Clinical Research Trial and/or monitoring experience. Thorough
knowledge of ICH-GCP guidelines + regulations, and comprehension of medical
terminology. Must have experience leading and managing groups within a CRO,
Biopharmaceutical setting.
Energized, polished and ready for your next challenge,
please call today!
Salary: above
market, highly competitive. Bonus 10-15%, full and thorough benefits package,
long term incentive plan!
Location: Canada
and/or USA, remote.
Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar
and Associates Inc., to apply for this exciting career opportunity.
Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.
ASSOCIATE OR SENIOR DIRECTOR STATISTICAL PROGRAMMING-REMOTE-USA OR CANADA TO $230K - $270K PLUS BONUS AND LTI BONUS
Our client in Clinical Research is experiencing
tremendous growth and as a result this newly created position has become
available. We are searching for an experienced Statistical Programming leader to
manage a team of like minded Quality driven professionals. This strategic
opportunity will lead and manage a group of Statistical Programmers working on
phase I-IV clinical trials in most Therapeutic categories.
Bring your technical expertise (Preparing SDTM data
mapping specification, ADaM dataset specifications, data reviewer's guides and
define .xml documents; perform QC review of documents; generate statistical
tables, listings and graphs in accordance with Statistical Analysis plans and
formats; ability to perform independent SAS programming validation of datasets;
contribute to continuous improvement of clinical standards and SOP's; design and
implement SAS macros) combined with your ability to instill a code of conduct to
a group of highly educated Statistical Programmers promoting corporate culture
and values is key to the success of this role.
Planning and organizing site specific events and
activities and working with functional group leaders will be part of your
mandate for this exciting high level career opportunity. Overseeing the
day-to-day operational effectiveness of the office including liaising with all
departments in order to achieve an environment of operational excellence, will
be part of the management responsibilities.
Lead deliverable tasks in a timely, accurate and
efficient manner to ensure quality and productivity leading study teams by
participating in resource planning and managing timelines of project
deliverables. Provide training, mentorship and technical guidance to the
Statistical Programmers.
A Master's degree in Statistics, Biostatistics, Bioinformatics,
Computer Science, Mathematics or other relevant field is required with at least
12 years of relevant industry experience using SAS in Clinical Trial analysis
and reporting OR a
PhD degree or equivalent in
statistical science, Mathematical analysis or related plus 10 years of relevant
experience leading teams.
Bring your In-depth knowledge of clinical trial data
processing and manipulation, hands on statistical programming and analysis and
we can arrange for a meeting of the minds with our client!
Salary:$230K - $270K 10% bonus or 401K and a full and
comprehensive benefits package.
Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar
and Associates Inc., to apply for this exciting career opportunity.
Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.
ASSOCIATE DIRECTOR, DIRECTOR OR SENIOR DIRECTOR OF CLINICAL DATA MANAGERS -
$180K - $250K PLUS 10%BONUS PLUS LTI BONUS
Our client is seeking an experienced Manager, who would
like to consider an Associate Director, Director or Sr. Director of Clinical
Data Managers career opportunity, managing a group of talented CDM's working on
mission critical Clinical Trials in a full service environment in every
Therapeutic category.
This high profile role will
Develop and manage clinical data management budget and resource plans and perform ongoing assessment and control for utilization of resources and budget.
Perform competitive benchmarking of clinical data operations to ensure that data
management techniques and procedures used are the best in class. Plan,
direct, and follow-up on the establishment of data management guidelines and
procedures which are in line with industry good data management practices.
Participate in and contribute to the corporate efforts in investigating,
establishing and implementing new and advanced systems, standards, and
procedures to improve the effectiveness of data capture and management.
Train, motivate, monitor and develop staff to assure high levels of performance
with strong professional and technical expertise. Complete annual and
semi-annual performance reviews. Plan, implement, and oversee staff training and
development process.
Planning and implementing data management timelines and deliverables and contributing to the overall project planning, progress tracking and reporting. Perform study resource planning, budgets and design and review case report forms (CFR's/eCFR's). Assist in performing client relationship management activities and participate in project bid defense meetings as required.
Participate in Project kick off meetings, investigators
meeting and similar. Review Data, issue and resolve queries; assist in resolving
medical coding discrepancies. Manage EDC, CRF to PDF CRF conversion process for
generating regulatory submission ready CRF packages.
Qualifications and Experience:
A Bachelors
or Master's degree in Health and/or Pharmaceutical Sciences,
Physical/Biological or Chemistry fields.
Five
years working as a Clinical Data Manager and at least 2 years managing teams of CDM's. Demonstrated an in-depth understanding of Clinical Trial Data Management concepts, processes and procedures, relevant issues related to or impacting Clinical Data Management, as well as Pharmaceutical Clinical Trial Regulations, Industry guidance, conventions and standards.Demonstrated a strong
leadership in Clinical Data Management activities and a desire to excel
in leading Data Management projects. Superior English communication skills are
considered an asset!
Compensation: Higher than average, and
commensurate with experience, bonus, Benefits and Pension.Start date: ASAP
Call Cris Murray 416 225-6386, VP Recruitment, J. Edgar
and Associates Inc., to apply for this exciting career opportunity.
Please send your CV to me directly for consideration: jedgar@sympatico.ca in either a word or PDF format. Once you submit your CV, I will personally call you back to discuss and disclose our clients details so that you can determine your interest level.
SENIOR DIRECTOR AND VP LEVEL CLINICAL DEVELOPMENT/OPERATIONS-CANADA OR USA-REMOTE
We are currently seeking two (2) committed,
skilled, and customer-focused professionals to join an award winning team as
Clinical Operations Leaders to develop and lead the Clinical Operations teams in
a highly successful, full service, Clinical Research Organization specializing
in every Therapeutic category from Phase I-IV. Bring your superior communication
skills, quality deliverables, stellar customer service, and flexibility in
meeting clients needs, and we have a dynamic career opportunity awaiting your
exploration!
The Clinical Operations
Leads serve as the clinical functional leads, accountable for the site
management/clinical monitoring delivery of assigned tasks and projects as per
scope. Will provide clear oversight and coordination of working across regions
to ensure clinical project and site deliverables are met. Bring your leadership,
mentoring, and technical support to the Clinical Operations team to ensure
quality deliverables and achievement of milestones and financial goals. These
high-profile roles will be responsible for tracking study progress and assessing
compliance of the conduct of clinical trials with regulatory requirements, the
clinical study protocol, study-specific plans, and Standard Operating
Procedures.
In these customer facing roles, you will interact with
Study Sponsors, Investigational sites, vendors and other functional departments
related to site management and clinical monitoring activities to ensure timely
and high-quality deliverables at all times. Ensure quality visibility of its
progress through CTMS/eTMF and/or tracking tools. Review study scope of work,
budget and protocol content and ensure the Clinical Operations team are aware of
the parameters. Ensure alignment of clinical activities to budget, including
identification of out-of-scope activities. Escalate to Project Managers any
clinical/site management deliverables (timeline, quality, and budget) at risk,
and any activities or requests which are out of contracted scope.
Develop, train, mentor, and guide clinical operations
team on protocol specific plans, guidelines and timelines, with support from
Clinical Operations Oversight, Project Management, Medical Monitoring, and
Sponsors, to foster a team culture that supports the Clinical Operations team
and results in staff retention. Coach and Mentor Clinical Operations Leads
regarding functional clinical delivery, evaluation of project risks, and
action-oriented implementation. Set priorities for the teams to complete and
manage on a regional and site level. Participate in scheduled Study Management
Team meetings for assigned projects, provide status updates and are accountable
for deliverables. Organize and Lead CRA team meetings to provide study updates
and perform training as needed. Author the Monitoring Plan and accountable for
the Clinical Operations teams (scheduling and report submission/finalization) to
ensure compliance with the Monitoring Plan and understand the monitoring
strategy by providing technical expertise. Liaise across various clinical
stakeholders to compile reports to track progress and performance metrics.
Act as point of contact for clinical site monitoring
and Investigator site questions/issue escalation. Perform site management,
review report progress status of the investigational sites. Communicate directly
with sites to provide direction, assess performance, and propose alternatives to
enhance performance of patient enrollment and data submission. Issue periodic
clinical trial Newsletters when required.
May conduct co-monitoring/preceptor oversight visits
with CRA’s to evaluate staff’s ability and performance level. May perform
Pre-Study, Site Initiation, Interim Monitoring/Remote, and or Closeout Visits as
required.
Lead site feasibility and selection process. Support
review of the documentation (review informed consent forms) to ensure clinical
site comply with ICH-GCP and relevant regulations. Assist with negotiation of
sites, contracts/budgets and prepare payments for Vendors/investigational sites.
Assist with Preparation and submission of regulatory documents to regulatory
agencies, authorities, IRBs and Research Ethics Committees. Collaborate with
functional teams including Medical Monitoring, Pharmacovigilance, and Quality
Assurance to ensure site compliance. Prepare, maintain and complete training on
study specific sponsor SOP’s. May participate in Business Development activities
including strategy, budget input and proposal development.
Equipment/Software: Microsoft Software (Word,
Excel, PowerPoint, Project, Outlook, Calendar, Contacts, and Tasks). Knowledge
of database systems, including Oracle InForm, MediData Rave, DFdiscover and
other Electronic Capture systems. Flex Database Trial Master File and Clinical
Trial Management System.
Qualifications include: Minimum BSc in life
sciences or related field, MSc and/or MBA preferred. At least 6-15 years of
Clinical Research Trial and/or monitoring experience. Thorough knowledge of
ICH-GCP guidelines + regulations, and comprehension of medical terminology. Must
have experience leading and managing groups within a CRO, Biopharmaceutical
setting.
Energized, polished and ready for your next challenge,
please call today!
Salary: above market, highly competitive. Bonus
10-15%, plus LTI bonus, full and thorough benefits package, long term incentive plan!
Location: Canada and/or USA, remote.
Call
Jason Edgar at 416 225-2628 for all the details.
DIRECTOR/SENIOR DIRECTOR BIOMETRICS, BIOSTATISTICS, CLINICAL RESEARCH CANADA OR US HOME BASED TO $250K - $280K PLUS 10%-15% BONUS AND LTI
Our growing, successful quality focused Clinical Research client is seeking a
Senior Director of Biostatistics to manage the daily activities of the
Biostatistics staff to ensure everyone is well-trained on SOP's and to promote
efficiency, quality and timelines in all project deliverables.
Bring your technical expertise, positive personality and business savvy nature
to the table and we have found you a match. Our client is looking for a
dedicated communicator, senior leader who is ready for their next challenge. You
will lead, guide, build and maintain key client relationships; be responsible
for departmental growth and development, including budgeting, forecasting and
proposal development. Mentoring and leading Biostatistics departments for all
clinical phase 1-4 projects will be the main focus of this career opportunity.
Key Accountabilities:
Provide leadership and expertise in resolving
complex operational and technical problems in support of division/company
objectives and projects, or as a resource to others. Maintain expertise in
industry norms, trends across biometrics and regulatory requirements.
Provide supervision to ongoing projects by applying
management skills, regulatory standards and requirements, and quality
management to ensure quality and timely deliverables.
Build and maintain relationships with assigned
clients to ensure biometrics services are well represented and that
communication with the client and the functional teams are clear.
Represent biometrics for the company in external
business development, regulatory or industry consortiums.
Represent biometrics functional service group in
external and internal audits, as well as qualification/maintenance audits
for vendors contracted.
Monitor and assess the progress status of ongoing
projects. Ensure high quality standards, on time delivery within budget for
all stages of the clinical trials – from the trial design, protocol
development, statistical analysis planning and execution, to the writing of
statistical sections of the Clinical Study Reports or the generation of
publications of trial results.
Support cross-functional biometrics process
development, making multi-disciplinary teams more effective by utilizing the
strengths of each biometrics functional team.
Provide leadership and expertise in day-to-day
statistical operations and development of statistical methodologies to solve
practical statistical problems.
Serve as a principal level biostatistician, working
effectively with interdisciplinary teams to contribute to drug development
at the study and drug compound levels. Provide statistical consultation to
trial medical/clinical personnel when required.
Participate in development of study concepts and
study protocols.
Lead statistical and programming teams on assigned
projects. Plan and manage resources, timelines, and quality of statistical
and programming deliverables.
Perform planned, ad hoc, and/or exploratory
statistical analyses.
Write Statistical Analysis Plans, Statistical
Reports, and statistical methodologies sections of Clinical Study
Reports, publications, abstracts, posters, presentations, etc. Review
statistical documents generated by others.
Perform independent validation of statistical
results generated by others and perform third level Quality Control review
on statistical and programming deliverables before they are released to the
clients.
Interact with regulatory agencies and support
client in New Drug Applications/Biologic License Applications. This includes
participating as a statistical liaison to the regulatory agency on behalf of
the client and ensuring documentation, statistical results, and study
datasets meet the regulatory agency’s requirements and expectations (e.g.,
CDISC).
Mentor and supervise direct and indirect
subordinates. Perform semi-annual and annual performance reviews and prepare
developmental plans for direct subordinates and indirect subordinates, where
appropriate, through contributing to the performance evaluation process.
Plan and manage resourcing plans by working with
the Project Management group in forecasting resource needs relative to the
roles of the personnel. Proactively and continually update the plan with
changes to demand, and identify/solution resourcing gaps or overage.
Participate in recruiting and staffing for
responsible functional area, as well as coaching, mentoring, and developing
staff members.
Contribute to the company’s management team
function and activities.
Qualifications and Experience:
A Ph.D. degree in statistical science, mathematical
analysis, or related fields with at least 12 years of relevant experience or
a Master’s degree in these fields with at least 15 years of relevant
experience.
Minimum of 4 years managing people, with
demonstrated exceptional ability and performance.
Significant contribution, and/or
outstanding/sustained performance may be used in lieu of the requirement on
the number of years of relevant experience.
This high level position reports into a senior executive who reports into
the President. Work in tandem with a strong team to reach new heights in
Clinical Research and have the autonomy to act as a business owner with an
entrepreneurial spirit.
SENIOR BILINGUAL CLINICAL RESEARCH ASSOCIATE TO $160K, PLUS 10% BONUS, CAR ALLOWANCE, FULL BENEFITS. WORK FROM HOME
Our client, specializing
in Clinical operations is searching for a Senior Bilingual Clinical Research
Associate where you will be responsible for monitoring, reporting, tracking
study progress, and assessing compliance of the conduct of clinical trials with
regulatory requirements, the clinical study protocol, study-specific plans, and
Standard Operating Procedures.
The role includes
leadership of the Clinical Operations study team as well as assessment and
direction of other Clinical Operations staff assigned to studies.
We are looking for an interactive team player who knows how to work with
study sponsors, investigational sites and vendors to enable timely and high
quality initiations and completions of Clinical Trials. Our client needs your
ability to identify, evaluate and qualify investigators and investigational
sites for participation in clinical trials.
Your ability to compile documentation for qualification
of clinical sites and ensure they are compliant with ICH-GCP and relevant local
regulatory bodies will enable your success in this newly created role.
Bring your keen sense of
contract negotiations to collectively participate in and prepare presentations
for clinical trials initiation meetings and or training sessions.
Perform on-site monitoring of clinical studies and document monitoring
activities through submission of monitoring reports to Clinical Operations
management for review. Responsible
for site management.
Requirements: Bachelors
degree in Life Sciences or Health related field.
Minimum of 5 years of experience in monitoring clinical trials in the
field required. Excellent written
and oral presentation skills, thorough knowledge of GCP's and ability to travel
to local study sites up to 40%.
Salary: $160K.
Bonus: 10% annual bonus, car allowance and other
relevant expenses plus full health benefits package, RRSP contribution and 4
weeks paid vacation.
DIRECTOR OR SR DIRECTOR OF CLINICAL DATA MANAGERS, REMOTE, PLUS 10% - $15% BONUS, PLUS LTI BONUS - BENEFITS AND INCENTIVES TO $160K - $220K
We are currently seeking an experienced leader to
manage a group of talented Clinical Data experts working on mission critical
Clinical Trials in every Therapeutic category.
In
this leadership role, the incumbent will
develop and manage a clinical data management budget and resource plans while
performing ongoing assessment and resource management of the group. As Director,
you will Manage client project portfolios as part of a full service team of
management leaders. This position requires maintenance of strong client
relations and assisting in the development of project bids for new projects.
As Director, you will assure timely availability of the clinical data capture
instruments and databases, and contribute to their completeness, validity, and
effectiveness. In this position, the incumbent will work to integrate the
operations of Clinical Data Management with the requirements of the Quality
Assurance, Project Management, Biostatistics, Statistical Programming, and
Medical Writing functions to assure cooperative realization of corporate
objectives and to optimize the productivity and effectiveness of clinical data
management.
The Director will; perform competitive benchmarking of clinical data operations
to ensure that data management techniques and procedures used are the best in
class, plan, direct, and follow-up on the establishment of data management
guidelines and procedures which are in line with industry good data management
practices, train, motivate, monitor and develop staff to assure high levels of
performance with strong professional and technical expertise. Completing annual
and semi-annual performance is also within the responsibility of the Director.
Qualifications and Experience:
A Bachelor
or Master degree or higher in:
Clinical Research Management, Pharmacy or Pharmaceutical Sciences, Epidemiology
or HealthCare Management, Statistics or Biostatistics, Mathematics, Biology or
Chemistry fields or a similar Research science based degree.
Five
years working as a Clinical Data Manager and at least
5 years leading teams in Clinical Data Management. We are looking
for a demonstrated in-depth understanding of Clinical Trial Data Management
concepts, processes and procedures and relevant issues related to or impacting
Clinical Data Management, as well as Pharmaceutical Clinical Trial Regulations,
ICH - GCP compliant to the FDA, Health Canada and other global regulatory
bodies.
Compensation:
commensurate with experience in the $160- $220K range plus bonus, benefits and
other incentives. Start date: ASAP
Please call me directly 416 225-6386 and please send your updated Resumes for consideration. Thank you, Cris Murray, jedgar@sympatico.ca
ASSOCIATE DIRECTOR/DIRECTOR STATISTICAL OPERATIONS WFH OR TORONTO BASED, TO $ 220K BASE PLUS BONUS, BENEFITS
This position functions as a technical and operational leader interfacing with
clients and leading internal statistical and programming teams to achieve
clinical development project/program objectives. The accountabilities of this
position are described below.
2.
Coach, mentor, develop, provide technical review, advice and expertise to direct
subordinate Biostatisticians and Statistical Programmers as well as indirect
subordinate Biostatisticians and Statistical Programmers assigned to the
program/projects.
3.
Perform semi-annual and annual performance review and develop developmental
plans for direct subordinates and, where appropriate, indirect subordinates
through contributing to the performance evaluation process.
4.
Provide statistical oversight on projects in the assigned drug development
programs/projects, ensuring sound statistical methodologies in study design,
sample size estimation, statistical analysis planning, statistical modeling,
data handling, analysis and reporting.
5.
Provide statistical input in protocol design and development. Participate in the
writing of trial protocols and research proposals.
6.
Serve as a principal level Biostatistician, working effectively with
interdisciplinary teams to contribute strategically (through innovative ideas or
applications) to drug development and commercialization at the study and drug
compound/therapeutic areas levels.
7.
Review and provide input to clinical data management deliverables, including but
are not limited to the following: eCRFs, eCRF Completion Instructions, data
validation specifications, Data Review Plan (and the ongoing data review tables,
listings, and figures in accordance with the Plan), and Data Management Plan.
8.
Write Statistical Analysis Plans, Statistical Reports, and statistical
methodologies sections of Clinical Study Reports. Perform peer review of SAPs
and other technical documents written by others.
9.
Perform hands on statistical analysis and modeling, and maintains expertise in
state-of-the-art statistical methodology and regulatory requirements.
10.
Validate core statistical tables, listings, and figures programmed by
statistical programmers and/or biostatisticians, ensuring that core results for
each responsible trial are complete and accurate. Perform overall Quality
Control review on statistical deliverables before they are released to the
clients.
11.
Review and confirm ADaM dataset specifications. Perform quality control
activities on ADaM datasets programmed by other statistical programmers and
biostatisticians.
12.
Provide statistical consultation to medical and clinical trial personnel for the
publication of trial results, and participate in the writing of abstracts,
manuscripts, posters, and presentations.
13.
Act as a consultant to less experienced biostatisticians.
14.
Ensure all study level as well as drug program level statistical and programming
activities are conducted in compliance with relevant regulatory requirements and
applicable standards/conventions.
15.
Interact with regulatory agencies and support sponsor in new drug application.
This includes participating as a statistical liaison to the regulatory agency on
behalf of the sponsor company and ensuring documentation, statistical results,
and study datasets meet the regulatory agency’s requirement/expectation (e.g.
CDISC).
16.
Perform statistical and programming resource management, capacity analysis,
benchmarking and metrics. Participate in the continuous improvement and
maintenance of statistical and programming governing documents.
17.
Contribute to organization development and growth by participating in the
interview and evaluation process for professional applicants.
BIOSTATISTICIAN WORK FROM HOME ANYWHERE IN USA TO $230K, 401K AND FULL BENEFITS
We
are searching for several senior talented Biostatisticians who will be
accountable for developing, applying and/or providing expertise in clinical
trial statistical and programming methods and techniques to effectively manage
and complete statistical and programming projects, and to support the company’s
mission, strategies, customers and priorities. In addition to the technical
accountabilities, this position assumes project management responsibilities in
directing and managing statistical and programming team activities for clinical
trials from the development of study protocols to the completion of study
reports. May represent division and the company, participate in business
development and customer relationship management activities, and provide
leadership in executing divisional and corporate plans.
Provide leadership/expertise in day to day
statistical and programming team operations and in resolving complex
problems for assigned projects, or as a consultant to others.
May represent division or company - provide
leadership in major divisional/corporate efforts and in executing divisional
or corporate plans. These efforts may include, but not limited to, the
following:
- Providing leadership/expertise in research and development of statistical
methodologies.
- Investigating and implementing new technologies, processes and
procedures.
- Developing and executing customer relationship management plans.
- Participating in new business development and bidding processes.
Act as Lead Biostatistician/Teammate
Biostatistician to interact with clinical trial sponsor companies, and
oversee projects for a sponsor company and/or for given therapeutic areas.
Lead assigned projects by applying project
management skills, statistical and programming techniques to deliver quality
and timely deliverables.
Plan, develop and monitor timelines for statistical
and programming activities in accordance with medical/clinical activities
for assigned projects. Jointly with immediate management, assess statistical
and programming resource needs and manage the assigned resources to the
projects.
Write Statistical Analysis Plans (SAPs) for
assigned projects. Perform review on the SAPs written by others.
Provide statistical input into the development of
study concept, protocol synopsis, protocol, and protocol amendments.
Perform review of clinical trial documents,
including but not limited to the following: study concept sheet, protocol
synopsis, protocols and amendments, statistical and programming documents
generated by others, and clinical study reports or publications.
Develop or perform review of statistical
programming technical specifications, which include but not limited to the
following: clinical trial data handling rules, statistical
derivations/algorithms, SDTM and ADaM dataset specifications, and
statistical testing/modeling approaches.
Perform quality control (QC) activities on
statistical datasets such as SDTM and ADaM datasets. These activities
include but not limited to the following: perform independent statistical
programming to validate the datasets, perform QC review of the datasets,
assess and recommend resolutions on discrepancies between the datasets
generated by two Statistical Programmers or Biostatisticians.
Perform quality control (QC) activities on
statistical analysis results or data displays such as statistical summary
tables, listings, and graphs (TLGs). These activities include but not
limited to the following: perform independent statistical programming to
validate the TLGs, perform QC review of the TLGs, assess and recommend
resolutions on discrepancies between the results generated by two
Statistical Programmers or Biostatisticians.
Generate or perform QC on clinical trial patient
randomization codes and treatment assignments. Oversee IxRS (IVRS and IWRS)
implementation of patient randomization codes and treatment assignments for
assigned projects.
Provide statistical and programming input into
clinical trial Case Report Forms (CRF) design for assigned projects, and may
provide input to the database design data flow, variable naming conventions
and data structure, etc. when required.
Participate in clinical trial kick off meeting,
investigators meeting, and ongoing trial management team meetings as per
project requirements.
Write statistical and results sections of the
Clinical Study Report, or perform QC review of the CSR.
Provide statistical and programming support to
clinical trial results dissemination activities, such as generation of data
reports for abstracts, manuscripts, posters, and presentations, etc.
With assistance from the Archivist, archive study
documentation upon the completion of final Study Reports.
Participate and contribute to the training,
mentoring, and development of new Biostatisticians or Statistical
Programmers.
Adhere to company governing documents (policies,
SOPs, work instructions, templates and checklists), may contribute to the
further development of these documents.
Contribute to organization development and growth
by participating in the interview and evaluation process for job applicants.
Plan and carry out professional development.
Qualifications and Experience:
A Ph.D. degree
or equivalent in statistical science, mathematical analysis or related
plus 3 years of relevant experience
or a Master’s degree plus 4 years
relevant experience with demonstrated ability and sustained performance at the
Ph.D. level.
STATISTICAL PROGRAMMER-INTERMEDIATE OR SENIOR-WFH ANYWHERE IN CANADA AND US, BONUS PLUS BENEFITS
We are currently seeking
experienced Statistical Programmers at Intermediate and Senior levels.
Good communication skills and a can do attitude will gain
you access to a growing team of Biostatisticians and Statistical Programmers at
an award winning, high delivery quality firm.
As Statistical Programmer you will: Perform data conversion
between datasets with two different formats according to conversion
requirements/specifications, conversion of Excel data records to SAS datasets,
non-CDISC compliant datasets to CDISC compliant datasets. You will assist in
developing SDTM data mapping specifications. Program SDTM and ADaM datasets
according to approved dataset specifications. Generate complete and accurate
statistical tables, listings and graphs (TLGs) in accordance with Statistical
Analysis Plans and well defined formats. Develop and test SAS programming codes
for clinical trial database logical checks and data reports for ongoing data
review. Perform SDTM CRF annotation or QC activities on aCRFs generated by
others. Document data and programming information in accordance with SOPs and or
clinical trial sponsor specific requirements as well as archiving clinical trial
data (raw data, SDTM and ADaM datasets) and programming documentation.
Requirements and Qualifications: A Master Degree in
Statistics, Biostatistics, Bioinformatics, Computer Science or Mathematics with
at least 1-3 years experience using SAS. SAS certification is an asset and
preferred. Must have experience includes the ability to perform data conversion
between datasets with two different formats according to conversion
requirements/specifications.
Most importantly, you should have experience with all
elements of the work you will perform; detailed above.
Salary - Commensurate with experience, higher than average
salaries with Bonus, benefits and pension!
Location -
USA or CANADA or SHANGHAI
SENIOR TO PRINCIPAL BIOSTATISTICIANS TORONTO BASED OR WORK FROM HOMEOUTSIDE OF GREATER GTA TO $200-$235K, PLUS 10% BENEFITS, PENSION
We are searching for several junior to intermediate talented Biostatisticians
who will be accountable for applying and/or providing expertise in statistical,
programming, and data management methods and techniques to effectively enable
decision making in support of the company’s mission, strategies, customers and
priorities. Key responsibilities: Lead efforts in resolving day to day work
related issues and problems, improving efficiency, quality, and productivity of
the operation; enhancing customer relationships and improving customer
satisfaction.
Research and development of statistical methodologies. Investigate and implement
new technologies, processes and procedures. Participate in developing and
executing marketing strategies and participate in developing and executing
customer relationship management plans. Participate in business development and
maintenance activities. Perform review for clinical study protocols and
statistical, programming, and data management documents generated by others.
Qualifications and Experience:
A Ph.D. degree or equivalent in Statistical Science, Mathematical Analysis, or
related field plus 1 to 2 years relevant experience or a Master’s degree plus 4
to 5 years relevant experience with demonstrated ability and sustained
performance.
Cris Murray 416 225-6386 Email resume in Word format to: jedgar@sympatico.ca
MANAGER OR ASSOCIATE DIRECTOR OF CLINICAL DATA MANAGERS TO $140K - $160K PLUS BONUS AND BENEFITS
Our client is seeking an
experienced Manager or Associate Director of Clinical Data Managers, managing a
group of talented CDM's working on mission critical Clinical Trials in every
Therapeutic category.
This high profile role will
Develop and manage clinical data management budget and resource plans and
perform ongoing assessment and control for utilization of resources and budget.
Manage client project portfolios in
conjunction with other corporate executives. Maintain strong client relations.
Assist in the development of project bids for new projects.
Assure timely availability of the
clinical data capture instruments and databases, and contribute to their
completeness, validity, and effectiveness.
Integrate the operations of Clinical Data Management with the requirements
of the Quality Assurance, Project Management, Biostatistics, Statistical
Programming, and Medical Writing functions to assure cooperative realization of
corporate objectives and to optimize the productivity and effectiveness of
clinical data management.
Perform competitive benchmarking of clinical data operations to ensure that data
management techniques and procedures used are the best in class. Plan,
direct, and follow-up on the establishment of data management guidelines and
procedures which are in line with industry good data management practices.
Participate in and contribute to the corporate efforts in investigating,
establishing and implementing new and advanced systems, standards, and
procedures to improve the effectiveness of data capture and management.
Train, motivate, monitor and develop staff to assure high levels of performance
with strong professional and technical expertise. Complete annual and
semi-annual performance reviews. Plan, implement, and oversee staff training and
development process.
Responsible for planning
and implementing data management timelines and deliverables and contributing to
the overall project planning, progress tracking and reporting. Perform study
resource planning, budgets and design and review case report forms
(CFR's/eCFR's). Assist in performing client relationship management activities
and participate in project bid defense meetings as required.
Participate in Project kick off meetings, investigators
meeting and similar. Review Data, issue and resolve queries; assist in resolving
medical coding discrepancies. Manage EDC, CRF to PDF CRF conversion process for
generating regulatory submission ready CRF packages.
Qualifications and Experience:
A Bachelors
or Master's degree in Health and/or Pharmaceutical Sciences,
Physical/Biological or Chemistry fields.
Five years
working as a Clinical Data Manager and at least
2 years managing teams of CDM's.
Demonstrated an in-depth understanding of Clinical Trial Data Management
concepts, processes and procedures, relevant issues related to or impacting
Clinical Data Management, as well as Pharmaceutical Clinical Trial Regulations,
Industry guidance, conventions and standards.
Demonstrated a strong
leadership in Clinical Data Management activities and a desire to excel
in leading Data Management projects. Superior English communication skills are
considered an asset!
Compensation:
$140-$160K base, plus 10% bonus, Benefits and Pension.
Start date:
ASAP
MANAGER CLINICAL DATA STANDARDS TO $125K - $140K, GREATER TORONTO AREA
We are currently seeking a
Clinical Data Standards compliance expert with the latest published electronic
regulatory submissions standards for: CDISC - SDTM - ADaM and Define XML,
Controlled Terminology (CT) published by the CDISC, the National Cancer
Institute (NCI) and other clinical trial review bodies, eCTD's, Study Data
Standards documents and any other relevant electronic submissions guidance
issued by the USFDA, PMDA(as an example) and other global regulatory agencies.
The role of the Manager is to maintain a compliant
library of metadata specification templates to ensure the efficient production
of compliant regulatory submissions and databases. The Manager will lead the
ongoing review of departmental processes to ensure that deliverables are
produced following the most up to date compliance requirements and protocols.
The Manager will also review and approve the draft of the SDTM and the ADaM
prior to release of the specifications to clients prior to the production of the
SDTM and ADaM databases. As Manager, you will be training teams on CDISC
compliance updates and regulatory submission updates. This role will also help
identify strong CDS team members within the Statistical Programming teams in
order to develop them as SMEs. As a CDS expert, the Manager will participate in
helping to ensure compliance and adherence to corporate governing documents when
required.
You must have a Master degree in Statistics, Computer
Science or a relevant field with 5-8 years of Clinical Research experience. You
must be an expert in the most up to date and compliant Clinical Data Standards
as mentioned: CDISC standards to specify, program and validate SDTM and ADaM
compliant databases for numerous therapeutic areas. We are looking for someone
with experience supporting eCTDs for individual studies and integrated safety
and efficacy analyses. The incumbent must have in depth knowledge of clinical
trial data management, statistical programming and analysis requirements for
assembling and presenting trial results to regulatory agencies. Experience with
multiple Regulatory agencies is preferred: FDA, Health Canada, MHRA, PMDA,
ANVISA, EMEA etc. This position
requires an experienced personnel Manager and an effective communicator in order
to work with experts at all levels of the organization and with client contacts.
Salary: $125K to $140K
CLINICAL TRIAL MANAGER TO $85K - $105K, FULL BENEFITS AND 10%BONUS, WFH CANADA OR USA
JOB ACCOUNTABILITIES:
1.
Interact with personnel from study sponsors, investigational sites, vendors, and
our client's functional groups to enable timely and high quality initiation and
completion of clinical trials. This includes broader clinical trial and project
management support across Clinical Operations, Biometrics, Safety, and
Regulatory functional groups.
2.
Lead the site feasibility and selection process. Compile documentation for
qualification of clinical sites. Support review of the documentation to ensure
clinical sites comply with ICH-GCP and relevant local regulations.
3.
Assist with preparation and submission of regulatory documents to responsible
authorities and IRB/ECs.
4.
Responsible for set-up and maintenance of studies in Clinical Trial Management
System (CTMS) and Trial Master File (TMF), working with the Clinical Trial
Assistant(s).
5.
Establish, maintain, and archive files of essential documents from investigative
sites and for inclusion in Trial Master Files. These files must be maintained in
a fashion so that they are continuously available for audit and completion for
archive.
6.
Assist in review of documentation of information provided to study subjects,
including informed consent forms.
7.
Assist in working with meeting planners and vendors to arrange for investigator
meetings, off-site client or internal departmental meetings.
8.
Liaise across various clinical trial stakeholders to compile reports to track
progress/status and clinical trial risks across all investigational sites.
9.
Contribute to the development of documents that facilitate or describe the
management of the clinical trial. Examples of such documents include, study
guides or manuals, and information collection tools.
10.
Responsible for the shipment and tracking of trial documents (site binders,
manuals, guides, etc.)
11.
Record and inventory visit reports received from monitoring staff.
12.
Work with our client and vendor staff to maintain study portals, web sites, or
newsletters.
13.
Assist with processing vendor invoices, investigator payments, and expense
reports.
14.
Prompt study team staff to provide timely and accurate reports of travel
expenses.
15.
Participate in the development and maintenance of, and adhere to departmental
SOPs and guidelines.
16.
Support business development efforts directly by supporting task-based
activities during RFPs and bid cycles, and indirectly by building trust-based
relationships with clients through performance, reliability, and strong customer
service.
17.
Prepare, maintain, and complete training on study-specific and (or) applicable
sponsor SOPs.
18.
Support sites in their efforts to prepare for audits conducted either by
sponsors or regulatory authorities.
19.
Plan and carry out professional development.
20.
Provide support in Clinical Operations, Project Management, or other functional areas as required.Please call Cris Murray 416 225-6386, J. Edgar and Associates Inc. to find out more details. Please send resume to me directly: jedgar@sympatico.ca
CLINICAL PROJECT MANAGER TO $85K - $120K PLUS 10% BONUS, WFH ANYWHERE: CANADA OR USA
We are seeking a Clinical Project Manager to drive continued success in this
exciting clinical research field as we are seeking committed, skilled, and
customer-focused individuals to join our clients winning team
as a Clinical Project Manager (focused on Biometric Project Management)
for our Toronto/Markham, Ontario, Canada location.
Key Responsibilities:
The incumbent is responsible for defining project scopes and estimating budgets,
planning, directing, controlling project activities, managing resources and
budgets, as well as project team performance of cross-functional teams engaged
in clinical research and development activities. This position is also
accountable for reporting of project progress status to our clients internal
management and its clients. These activities may include but are not limited to
managing projects with activities focused on clinical operations, data
management, statistics, medical writing, subject randomization and drug supply
management (IWRS), administration of data monitoring and adjudication
committees, as well as preparing drug submissions to regulatory agencies.
When required, the incumbent may assist the organization in responding to and
preparing for Request for Information and Request for Proposals, and
subsequently defining work scopes and budgets, and performing contract
administration activities.
When required, the incumbent may perform clinical trial planning, management, and site monitoring from the initiation of a trial to its closure.
Qualifications and Experience:
Please call Cris Murray at 416 225-6386 to find out more details. Email resume in Word format to: jedgar@sympatico.ca
2 CLINICAL DATA MANAGERS, INTERMEDIATE AND SENIOR TO $95K - $140K PLUS 10% BONUS, WFH ANYWHERE IN Canada OR USA
We are seeking 2 CDM's
in total.
The Clinical Data
Manager's will lead assigned data management projects by applying project
management skills and data management techniques to ensure timely and quality
deliverables. The incumbents will manage project timelines and coordinate
activities for assigned projects, and be responsible for the development of Data
Management Plans, clinical trial case report forms, databases, and overseeing
data processing.
A bachelors' degree in health science, registered
nurse, or higher equivalent education in relevant disciplines, with
a minimum of 2-5
years experience in clinical trial data management, and demonstrated leadership
ability to effectively manage clinical trial data management activities and
integrate them with the entire clinical trial operations; must communicate
effectively, orally and in writing. Experience with clinical trial electronic
data capture systems and in particular must have experience using MediData Rave.
Solid understanding of clinical drug development process and knowledge of FDA
regulatory requirements and ICH/GCP guidelines is required. In addition, the
incumbent must have excellent oral and written communication skills and to apply
such skills in logical and algebraic operations.
To drive continued success in this exciting clinical research field, we are
seeking committed, skilled, and customer-focused individuals to join our clients
winning team as a Clinical
Data Manager.
key
accountabilities are:
Plan, manage, control
and performs data processing and management activities for assigned
projects. These tasks are performed in a timely and accurate manner and in
compliance with trial sponsors’ requirements.
Lead assigned data processing and management
projects by applying project management skills, data processing and management
techniques. Manages timelines and coordinates activities for assigned projects.
Specify
database validation checks for assigned studies. Lead efforts in developing and
maintaining standard database validation checks for common modules as well as
for therapeutic/drug area specific modules.
Define and monitor clinical trial dataflow and
quality control processes in accordance to corporate SOPs, Good Working
Practices, and unit guidelines. Perform clinical trial site monitors’ training
on dataflow and quality control processes.
Design and review patient
Case Report Forms and database schema. Test data capture/entry screens.
Accurately and efficiently
validate electronically captured data. Write clear queries on missing data and
data points failing pre-defined range checks and/or logical checks. Lead
efforts in building a standard query library for common database modules as well
as for therapeutic/drug area specific modules.
Perform quality control procedures on assigned
database during the trial, and additional database closure checks at the end of
the study.
Train and supervise Data
Entry personnel and junior data management personnel on study procedures, study
specific handling and management of trial data.
Validate and distribute study progress status
reports to internal and external study team members.
Assist in resolving data coding discrepancies
resulting from the coding of medical events, treatment procedures and
medications.
Maintain and prepare for final archival of data management documentation
relevant to the assigned clinical trials, and assist the corporate archivist in
assembling and archiving clinical trial data and study documentation.
Cooperate with and assist, when required,
data management quality assurance (QA) personnel in performing QA procedures on
trial Case Report Forms (CRFs), database schema and databases for assigned
studies.
Salary - $95-$140K plus bonus and full health benefits. Start: ASAP.
Please call Cris Murray 416 225-6386 for all the details.
SENIOR PHARMACOKENETIC SCIENTIST, TO $150K - $170K PLUS BONUS
Perform pharmacokinetic and pharmacodynamic (PK/PD) data analysis, modeling, and reporting to support clinical trial designs, compound development plans, and regulatory submissions for the Statistical Science Unit
KEY
EQUIPMENT/SOFTWARE USED:
Microsoft Word, PowerPoint, Excel, Outlook, Relational database concept, SAS and sample size calculation software and
WinNonLin or other relevant pharmacokinetic software.| REQUIREMENTS: |
2.
In-depth knowledge of clinical development, clinical
pharmacology, and PK/PD is required.
5.
Good communication and interpersonal skills.
6.
Skilled in scientific writing and data interpretation.
7.
Demonstrated ability for logical thinking, vision, and creativity necessary to
function effectively with little structure or supervision.
8.
Ability to multi-task, managing multiple projects
with competing and aggressive timelines.