Senior Manager, Global Data Generation
Core
Manage operational aspects of Investigator Sponsored Trials (ISTs), Cooperative Group studies, and real-world evidence studies for oncology immunotherapy development.
Role type
Senior Manager, Global Data Generation
Builds
Operational support for global non-sponsored research programs
Domain
Biopharmaceuticals / Oncology
Deliverable
client delivery
Required skills
Clinical trial management, IST program management, budget negotiation, Fair Market Value analysis, contract execution, document management, stakeholder management, data tracking and reporting
Preferred skills
Oncology experience, advanced degree (PharmD, PhD), experience with iEnvision ISR platform, experience with IQVIA Grant Plan for Investigators
Technologies
iEnvision ISR platform, IQVIA Grant Plan for Investigators, MS Office suite
Responsibilities
Manage operational aspects of studies including protocol review, document management, contract execution, and drug shipments; Manage concept proposal intake and submission portal; Prepare materials for Scientific Review Committee meetings; Obtain internal approval of study budgets and conduct Fair Market Value analysis; Track study progress and milestones for payment; Manage and forecast drug supply; Collaborate cross-functionally with medical affairs, clinical development, and regulatory teams.