Medical Affairs Operations Manager

Location

West Chester, PA | United States

Job description

Stefanini Group is hiring!

Stefanini is looking for Medical Affairs Operations Manager in West Chester, PA Location

For quick Apply, please reach out to Shubham Singh - call:

Work Hours: M-F (40 hours)

Work Location: West Chester, PA

Shift: 1st Shift (8:00 AM - 5:00 PM)

• This role will support evidence generation within GMA, across therapeutic areas by supporting the execution, oversight, processes, and governance of GMA led clinical studies, including local Medical Affairs sponsored studies. The role will also focus on quality, and inspection readiness initiatives in partnership with pharmacovigilance (PV), Global Clinical Quality (GCQ) and Global Clinical Operations (GCO) as needed.
• Specific responsibility will include oversight of the global processes for study governance and tracking of these studies including but not limited to, late phase company sponsored studies and regional/local Medical Affairs Studies. This role will be required to interact directly with internal and external stakeholders in order to ensure the execution of medical affairs study related activities is on time and on budget. This role will be responsible for maintaining policies, SOPs, Work Instructions, and related supporting procedural documents essential for compliance as well as implementation and oversight of quality and inspection readiness initiatives.
• The Sr. Manager, GMA Evidence Generation reports to the Director of Evidence Generation.
• This position will require you to interact directly with internal and external stakeholders in order to ensure the timely execution of assigned tasks.
• This position will be responsible for adhering to policies and SOPs essential for compliance.
• This position reports to the Director of Evidence Generation.
• Travel Requirements: Minimal (limited regional and/or international travel)

Duties & Responsibilities:

• Global study oversight and tracking for Medical Affairs Company sponsored studies and evidence generation activities.
• Act as operational 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, prepare, and support governance presentations.
• Support quality initiatives including inspection readiness oversight for Medical Affairs Studies as well as development and support of quality process and procedures.
• Represent GMA in the review and development of various procedural documents related to late-phase Global Medical Affairs studies, inspection readiness and quality in alignment with the R&D GCO, Innovative Medicines, Clinical Development, Pharmacovigilance, Global Clinical Quality, GMA therapeutic area teams.
• Development and refinement of relevant policies, SOP and Work Instructions as applicable
• Sponsor Therapeutic Area review of ongoing studies to facilitate knowledge sharing, status updates and critical issue identification.
• Oversee Vendors to ensure accurate service delivery, required process or system updates and ensure continuous service/support.
• Provide support for Investigator Sponsored Studies, Collaborative Research and Compassionate Use programs as needed.
• Provide support for GMA Excellence & Evidence Generation initiatives as requested.
• Provide system support (clinical trial management system, intake portals) as needed.

Job tags

Salary

$47.25 per hour