Clinical Research Project Manager
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POST DATE 8/14/2016
END DATE 11/14/2016
North Wales, PA
JOB DESCRIPTIONProminent global pharmaceutical company is seeking an Clinical Research Project Manager to work in Upper Gwynedd, PA.
This is a twelve (12) month contract assignment with the possibility of extension/temp-to-hire.
Max pay is $44.45/hour
Under general supervision of manager or director, coordinates all aspects of planning and implementing observational or non-interventional research studies and activities such as primary data collection studies, chart review studies, database studies and molecular epidemiology studies.
Assist the research manager with study design (including protocol preparation, study questionnaires, and data analysis plan) and provide operational support for study conduct.
Prepare reports, meeting minutes, presentations, abstracts and manuscripts for internal and external audiences under the direction of the research manager.
Provide up to date and accurate communications on study status and study-related issues to internal and external stakeholders.
Authoring statements of work for outsourced projects
Leading contract activities through execution
Internal/external meeting management
Liaising with vendor and cross functional teams to communicate status or needs
Tracking timelines/deliverables, following up on action items, preparing data collection forms, tabulating and summarizing data for publications/final reports.
In addition, technical responsibilities may could include systematic literature reviews for information on disease and background risks for clinical and regulatory documents (e.g. filings, Risk Management Plans (RMP), Pediatric Investigational Plans (PIPs), Orphan drug applications (ODAs), regulatory responses, etc.).
Routinely provide assistance in authoring and coordinating the finalization of sections of Regulatory Documents such as CSRs, Interim Study reports, RMPs, Periodic Safety
Update Reports (PSURs) and PIPs.
Additional assignments may include leading departmental and cross-functional initiatives to improve efficiencies and assure compliance.
Master's degree (such as public health, epidemiology, outcomes research, behavioral sciences, health services research, biological sciences or public administration).
Three or more years' job related experience (e.g. clinical/ observational or non-interventional research), or equivalent experience a plus.
Experience with basic epidemiological methods, statistics, basic sciences, health outcome research or health economics and/or medical research preferred.
Must have strong communication (oral and written), multi-tasking, organizational and project management skills.
Pharmaceutical industry experience preferred. We are an equal employment opportunity employer and will consider all qualified candidates without regard to disability or protected veteran status.