Manager Medical Study Operations

Benefits

Additional Information

As a Manager, Medical Study Operations you are responsible for all operational aspects of Global Medical Affairs Oncology, including Investigator-Initiated Studies (IIS), Research Collaborations (RC), and Data Transparency requests across multiple products and new molecules. ensuring compliance with applicable standards and regulations. This position will require you to be on-site 4 days/week at our Sleepy Hollow, NY offices. If eligible, we can offer relocation benefits. We cannot offer a remote work option. A typical may include the following: - Manage multiple projects/programs, including IIS, Research Collaborations, and Data Transparency, with moderate direction. - Ensure proposals align with Areas of Interest, are complete, and reviewed by the appropriate governing bodies. Obtain all necessary approvals, including those from the Medical Affairs Review Committee (MARC), Collaborator/Partners, and Senior Management, for both original proposals and amendments. - Facilitate meetings and committees, including setting agendas, driving goals, documenting outcomes, and ensuring follow-up on action items. Coordinate scientific meetings with external investigators and the Field Medical Team. - Track and report study progress, data delivery, program impact, and other relevant metrics. - Ensure collection, tracking, and archiving of all relevant documents, including regulatory submissions, IRB/EC approvals, and Health Authority communications. - Ensure patent reviews, due diligence (e.g., OIG exclusion list, FDA debarment), and background checks for compliance. - Collaborate with Site Budget & Contracting, Legal, Procurement, and Sponsor Institution to ensure agreement meets study requirements. - Oversee study budgets, including Fair Market Value (FMV) analysis, approvals, and purchase orders (POs). Manage POs, achievements, invoicing, accruals, projections, and budget planning. Handle budget changes, reforecasts, and reconciliations while ensuring effective communication with partners. - Plan and coordinate drug campaigns with Drug Supply Functions, ensuring compliance with packaging, labeling, and country-specific requirements. - Manage drug shipments, resupply, expiry, quarantines, and destruction of unusable products. - Ensures timely receipt and reconciliation of Serious Adverse Events (SAEs) and Investigator Alert Letters (IAL) in compliance with regulatory requirements. - Coordinate internal review of publications, consolidate feedback, and document actions taken. - Ensure data capture in study management tools and document repositories for audit readiness. - Adhere to all relevant processes, training, and SOPs to ensure consistency, efficiency, and compliance. To be considered a minimum of BA/BS degree in a related field with 7+ years of industry or relevant professional experience in clinical research. Experience in oncology and/or antibody research is a plus. Experience with Investigated Initiated Studies is preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter. Please be ad

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