Manager Medical Study Operations
Regeneron
June 30, 2026
On-site
Sleepy Hollow, NY
Clinical Research and Development
Responsibilities:
- Manage operational aspects of Global Medical Affairs Oncology across Investigator-Initiated Studies (IIS), Research Collaborations (RC), and Data Transparency requests across multiple products and new molecules, ensuring compliance with applicable standards and regulations.
- Manage multiple projects/programs with moderate direction.
- Ensure proposals align with Areas of Interest, are complete, and reviewed by appropriate governing bodies; obtain required approvals for original proposals and amendments (including MARC, collaborators/partners, and senior management).
- Facilitate meetings/committees (agendas, goals, documentation, follow-up) and 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 relevant documents (regulatory submissions, IRB/EC approvals, Health Authority communications).
- Support 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 agreements meet study requirements.
- Oversee study budgets (FMV analysis, approvals, POs), including PO management, invoicing, accruals, projections, reforecasts, and reconciliations.
- Plan/coordinate drug campaigns; manage drug shipments, resupply, expiry, quarantines, and destruction of unusable products.
- Ensure timely receipt/reconciliation of SAEs and Investigator Alert Letters (IAL) per regulatory requirements.
- Coordinate internal publication reviews and consolidate feedback.
- Ensure data capture in study management tools and document repositories for audit readiness; adhere to relevant processes, training, and SOPs.
Qualifications:
- BA/BS in a related field; 7+ years of industry or relevant professional experience in clinical research.
- Oncology and/or antibody research experience (plus).
- Experience with Investigated Initiated Studies (preferred).
Application instructions:
- Apply now.
- Manage operational aspects of Global Medical Affairs Oncology across Investigator-Initiated Studies (IIS), Research Collaborations (RC), and Data Transparency requests across multiple products and new molecules, ensuring compliance with applicable standards and regulations.
- Manage multiple projects/programs with moderate direction.
- Ensure proposals align with Areas of Interest, are complete, and reviewed by appropriate governing bodies; obtain required approvals for original proposals and amendments (including MARC, collaborators/partners, and senior management).
- Facilitate meetings/committees (agendas, goals, documentation, follow-up) and 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 relevant documents (regulatory submissions, IRB/EC approvals, Health Authority communications).
- Support 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 agreements meet study requirements.
- Oversee study budgets (FMV analysis, approvals, POs), including PO management, invoicing, accruals, projections, reforecasts, and reconciliations.
- Plan/coordinate drug campaigns; manage drug shipments, resupply, expiry, quarantines, and destruction of unusable products.
- Ensure timely receipt/reconciliation of SAEs and Investigator Alert Letters (IAL) per regulatory requirements.
- Coordinate internal publication reviews and consolidate feedback.
- Ensure data capture in study management tools and document repositories for audit readiness; adhere to relevant processes, training, and SOPs.
Qualifications:
- BA/BS in a related field; 7+ years of industry or relevant professional experience in clinical research.
- Oncology and/or antibody research experience (plus).
- Experience with Investigated Initiated Studies (preferred).
Application instructions:
- Apply now.