Data Scientist
Company: Sigma Inc
Location: West Chester
Posted on: June 25, 2022
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Job Description:
TV8125 Remote Clinical Trial Project Manager, West Chester, PA 6
Months
Sigma Inc is currently looking for a -Clinical Trial Project
Manager -work remote
Job description:
Global strategic partner across therapeutic areas to support
evidence generation within GMA. This role will support the
tracking, processes and governance of GMA lead clinical studies,
compassionate use programs and external research coordination and
governance. Specific responsibility will include oversight of the
external investigator initiated study (ISS) program and
administration and execution of Internal Review Committee (IRC)
meetings to review external requests or research support.
This position will be required to interact directly with internal
and external stakeholders in order to ensure the timely execution
of medical activities on time and on budget.
Represent GMA in the review and development of various procedural
documents related to late-phase Global Medical Affairs studies and
ISS, in alignment with the R&D GCO Systems and Standards,
Specialty Clinical Development and GMA therapeutic area teams
Global study oversight and tracking for ISS, compassionate use
programs, and support the oversight of CSS as required
Support the Global ISS program
Oversee Vendors to ensure accurate service delivery, required
process or system updates and ensure continuous service/support
Act as support for regional and local Medical Affairs teams to
assist with study start up activities in partnership with GCO and
Procurement; e.g. SDC/protocol development, vendor selection,
convene study team, MARC presentation
Development and refinement of relevant policies, SOP and Work
Instructions
Work with internal stakeholders across regions, TAs and departments
to facility successful processes for data generation including late
phase study development and launch as well as Investigator
Sponsored Studies programs
Provide support for GMA Excellence & Evidence Generation
initiatives as requested
Qualifications:
Bachelor's degree in Biomedical Science and Pharmacy preferred
3 years in Medical Affairs experience
3 years of Clinical trial experience
Experienced and adept at working collaboratively across different
cross-functional teams such as commercial, R&D, health
outcomes, regulatory, pharmacovigilance and compliance/legal
Experienced and comfortable working in a matrix set up,
facilitating desired outcomes by integrating business partners from
various regions with different personal background
Limited regional and/or international travel travel -
10-15%
Keywords: Sigma Inc, Wilmington , Data Scientist, Other , West Chester, Delaware
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