Global Medical Affairs Research Grant & Study Manager

The GMA Research Grant & Study Manager

The GMA Research Grant & Study Manager is responsible for the operational management, coordination, and oversight of Medical Affairs-sponsored evidence generation activities across regions. This is a highly collaborative role that supports the generation of high-quality scientific evidence to advance patient care and inform medical strategy. Responsibilities include Investigator-Sponsored Studies (ISS), research grants, Phase IV company-sponsored studies, observational research, registries, real-world evidence initiatives, and other post-authorization research programs.The role also serves as the primary coordinator and administrator for the ISS and research grants process, ensuring efficient governance, review, contracting, tracking, reporting, and compliance. In this position, you will work closely with cross-functional teams and external partners to ensure studies are conducted in accordance with applicable regulations, company policies, quality standards, and evidence generation objectives. The role may also support expanded access/compassionate use programs and reimbursement studies. In addition, it collaborates with Clinical Development colleagues to support Phase III clinical development programs and facilitate alignment between development and post-approval evidence generation activities, contributing to a seamless evidence generation strategy across the product lifecycle.

What you will do

• Serve as the operational lead for the Investigator-Sponsored Studies (ISS) and research grants process, ensuring efficient administration and governance.
• Coordinate the end-to-end lifecycle of ISS and research grant activities, from submission through study close-out.
• Manage study contracts, milestones, budgets, payments, reporting requirements, and maintain accurate study documentation and tracking systems.
• Facilitate cross-functional collaboration with Medical Affairs, Clinical Development, Compliance, Legal, Finance, and external stakeholders to support evidence generation activities.
• Coordinate the planning, execution, oversight, and close-out of Medical Affairs-sponsored evidence generation programs, including Phase IV studies, observational research, registries, and real-world evidence initiatives.
• Monitor study timelines, deliverables, operational performance, and ensure studies are conducted in compliance with GCP, regulations, ethical standards, and company procedures.
• Support Phase III clinical development programs and drive alignment between development activities and post-approval evidence generation strategies.
• Support expanded access, compassionate use, and other special research programs, ensuring appropriate coordination, documentation, and tracking.
• Oversee external vendors and CROs, monitoring performance, quality, timelines, and budget adherence while proactively identifying and mitigating operational risks.
• Contribute to process improvements, SOP development, inspection readiness, and initiatives that enhance operational efficiency, compliance, and transparency across evidence generation programs.