Associate Manager Externally Sponsored Research
Core
Operational oversight of unsolicited investigator-sponsored research (ISS) and externally sponsored collaboration (ESC) requests, ensuring compliant study review, start-up, execution, and tracking of milestones.
Role type
Associate Manager, Externally Sponsored Research Operations
Builds
Research agreements, product supply, purchase orders, and regulatory documentation for external sponsors
Domain
Pharmaceutical R&D / Clinical Research Operations
Deliverable
client delivery
Required skills
Clinical trial project management, study operational management, regulatory compliance (GCP, ICH), budget and payment tracking, system of record management, cross-functional collaboration, data analytics
Preferred skills
Project management certification, knowledge of PhRMA code and OIG regulations, process improvement initiatives
Technologies
iEnvision, SharePoint
Responsibilities
Manage ESR program from proposal to closeout including SRC coordination and supply management; Execute compliant ESR processes and support audit readiness; Collaborate on research agreements and product supply forecasts; Develop metrics and KPIs for investment decisions; Oversee ESR system of record and data integrity; Manage team and stakeholder training
Seniority
Mid-Senior, hands-on IC with team management
