Externally Sponsored Research Manager
Core
Operational backbone for externally sponsored research in the USA, ensuring high-quality, compliant studies that inform practice and broaden patient impact.
Role type
Senior IC research operations manager
Builds
Externally sponsored research (ESR) programs and study execution
Domain
Pharmaceutical industry + clinical research operations
Deliverable
client delivery
Required skills
Clinical study management, Externally Sponsored Research (ESR) processes, Study management systems, GCP/ICH guidelines, Financial knowledge for study management, Contract and budget management, Risk mitigation, Stakeholder liaison
Preferred skills
Tumor type area expertise, Regulatory submission support (LOAs)
Technologies
ACCORD, VCV
Responsibilities
Coordinate cross-functional collaboration for study start-up and execution; Manage operational compliance with global/local policies; Ensure accurate and timely data entry into ESR management systems; Facilitate Local Strategic Alignment (LSA) governance meetings; Prepare research CDAs/CSAs; Monitor study performance and escalate risks; Maintain study budgets and ensure accurate payments; Support corrective action plans for off-track studies; Collaborate with Regulatory Affairs for LOA requests.
Seniority
Mid-level, hands-on IC
