Data Scientist

Company: Sigma Inc
Location: West Chester
Posted on: June 25, 2022

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