Externally Sponsored Research Specialist
Core
Manage Externally Sponsored Research (ESR) requests, conduct sponsor/investigator assessments, and oversee Fair Market Value (FMV) reviews for clinical studies.
Role type
Project Specialist - Externally Sponsored Research (ESR)
Builds
Clinical study proposals and research collaborations for Specialty Care, Vaccines, and General Medicines
Domain
Pharmaceutical / Clinical Research Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, Sponsor/Investigator assessment, Fair Market Value (FMV) review, Quality Control (QC), Protocol review, Budget verification, Stakeholder liaison, Data accuracy management
Preferred skills
Scientific discipline background, International project management experience, Process improvement, Risk analysis
Technologies
iEnvision, Microsoft Office (Outlook, Excel, Word, PowerPoint)
Responsibilities
Manage incoming ESR requests and liaise with global/local medical teams; Perform sponsor qualification checks and study outline reviews; Conduct FMV reviews and approval for external studies; Support CDA creation and management; Perform QC activities for ESR records and data within the system; Lead governance for Scientific Review Committee (SRC) meetings.
Seniority
Mid-level, hands-on IC