Manager Medical Study Operations
Core
Manage operational aspects of Global Medical Affairs Oncology, including Investigator-Initiated Studies, Research Collaborations, and Data Transparency requests.
Role type
Manager, Medical Study Operations
Builds
Operational execution of oncology research programs and data transparency initiatives
Domain
Life Sciences / Oncology / Clinical Research
Deliverable
client delivery
Required skills
Project management, regulatory compliance, budget management, contract negotiation, meeting facilitation, document archiving, adverse event tracking, publication review coordination
Preferred skills
Oncology experience, antibody research experience, Investigator-Initiated Studies experience
Technologies
Study management tools, document repositories
Responsibilities
Manage multiple projects/programs with moderate direction; Obtain necessary approvals from governing bodies; Facilitate meetings and committees; Track and report study progress and metrics; Ensure collection and archiving of regulatory documents; Oversee study budgets and purchase orders; Plan and coordinate drug campaigns; Manage drug shipments and inventory; Ensure timely receipt and reconciliation of Serious Adverse Events; Coordinate internal review of publications; Ensure data capture for audit readiness
Seniority
Manager, hands-on IC