Manager Medical Study Operations
Regeneron
7 hours ago
On-site
Sleepy Hollow, NY
Clinical Research and Development
Role: Manager, Medical Study Operations (Global Medical Affairs Oncology)
Responsibilities:
- Manage operational aspects of Global Medical Affairs Oncology, including Investigator-Initiated Studies (IIS), Research Collaborations (RC), and Data Transparency requests.
- Manage multiple projects/programs with moderate direction.
- Ensure proposals align with Areas of Interest, are complete, and reviewed by governing bodies; obtain approvals (including MARC, Collaborators/Partners, and Senior Management) for proposals and amendments.
- Facilitate meetings/committees (agendas, goals, outcomes, follow-up) and coordinate scientific meetings with external investigators and the Field Medical Team.
- Track and report study progress, data delivery, program impact, and relevant metrics.
- Ensure collection, tracking, and archiving of documents (regulatory submissions, IRB/EC approvals, Health Authority communications).
- Conduct patent reviews and compliance due diligence (e.g., OIG exclusion list, FDA debarment) and background checks.
- Collaborate with Budget & Contracting, Legal, Procurement, and Sponsor Institution to ensure agreements meet study requirements.
- Oversee study budgets (FMV analysis, approvals, POs, invoicing, accruals, projections, reforecasts, reconciliations).
- Plan/coordinate drug campaigns and manage drug shipments (resupply, expiry, quarantines, destruction).
- Ensure timely receipt/reconciliation of SAEs and Investigator Alert Letters (IALs).
- Coordinate internal publication reviews; 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 industry or professional experience in clinical research.
- Oncology and/or antibody research experience (plus).
- Experience with Investigator-Initiated Studies (preferred).
On-site: Sleepy Hollow, NY office, 4 days/week.
Relocation: available if eligible.
Application: Apply now.
Responsibilities:
- Manage operational aspects of Global Medical Affairs Oncology, including Investigator-Initiated Studies (IIS), Research Collaborations (RC), and Data Transparency requests.
- Manage multiple projects/programs with moderate direction.
- Ensure proposals align with Areas of Interest, are complete, and reviewed by governing bodies; obtain approvals (including MARC, Collaborators/Partners, and Senior Management) for proposals and amendments.
- Facilitate meetings/committees (agendas, goals, outcomes, follow-up) and coordinate scientific meetings with external investigators and the Field Medical Team.
- Track and report study progress, data delivery, program impact, and relevant metrics.
- Ensure collection, tracking, and archiving of documents (regulatory submissions, IRB/EC approvals, Health Authority communications).
- Conduct patent reviews and compliance due diligence (e.g., OIG exclusion list, FDA debarment) and background checks.
- Collaborate with Budget & Contracting, Legal, Procurement, and Sponsor Institution to ensure agreements meet study requirements.
- Oversee study budgets (FMV analysis, approvals, POs, invoicing, accruals, projections, reforecasts, reconciliations).
- Plan/coordinate drug campaigns and manage drug shipments (resupply, expiry, quarantines, destruction).
- Ensure timely receipt/reconciliation of SAEs and Investigator Alert Letters (IALs).
- Coordinate internal publication reviews; 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 industry or professional experience in clinical research.
- Oncology and/or antibody research experience (plus).
- Experience with Investigator-Initiated Studies (preferred).
On-site: Sleepy Hollow, NY office, 4 days/week.
Relocation: available if eligible.
Application: Apply now.