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Location

West Chester, PA | United States

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Job description

Description:

Title: Senior Manager, GMA Evidence Generation, GMA Excellence & Evidence Generation

Schedule for this position: M-F 8-5

Position Summary: 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 are 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 be required 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 postion reports to the Director of Evidence Generation.

Travel Requirements: Minimal (limited regional and/or international travel)

Essential 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 Theraputic 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.

Position Requirements:

Education Required: Bachelor's degree in Biomedical Sciences, Pharmacy or similar

Experience Required: 3 years of experience in Industry with relevant medical affairs experience and/or clinical trial experience Strong interpersonal skills with experience in project management, organization and tools

Experience Preferred: 5 years of experience in Industry with relevant medical affairs experience and/or clinical trial experience

Specialized or Technical Knowledge Licenses, Certifications needed:

Functional Knowledge: Knowledge of Good Clinical Practice and Good Pharmacovigilance Practice

Company/Industry Related Knowledge: Pharmaceutical experience including understanding of Medical Affairs including clinical trials (e.g. ISS, CR, Secondary Data Collections, PASS, NIS, Registries)

Job-Specific Competencies:

• Excellent interpersonal and communication skills, able to build strong working relationships with all stakeholders involved (Internal and external business partners)
• Able to work in a changing and flexible environment in an adaptive way with a "can-do" positive attitude and acts in a capacity where the individual's wide-ranging experience will add to the quality and outcome of business decisions
• 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
• Able to adopt a different working style when needed and dictated by a changing working environment (changing business needs and context)
• Strong problem identification and resolution skills with demonstrated ability to apply technology and process solutions o business related problems or opportunities
• Solid knowledge of project management, organization and tools; requires strong attention to details
• Clinical studies management experience

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