Clinical Trial Manager
Core
Manage clinical studies from synopsis to final deliverables (database lock, TLFs, CSR) for registrational BLA submissions in oncology cell therapies.
Role type
Senior Clinical Trial Manager (Oncology/Cell Therapy)
Builds
Clinical programs leading to FDA/Global regulatory submissions for TIL cell therapies
Domain
Biopharma / Oncology / Cell Therapy
Required skills
Clinical trial management (Phase 1-4), CRO/vendor management, US and Global regulations (ICH-GCP, FDA-CFR), risk management, data integrity oversight, cross-functional team leadership
Preferred skills
Experience with gene-edited therapies, IL-12 tethered TILs, next-generation IL-2, precision immuno-oncology
Technologies
EDC, IWRS, Central Laboratories, ePRO, eDiary, DMC/DSC
Responsibilities
Develop budget items, milestones, and timelines; oversee cross-functional team execution; lead vendor identification and qualification; critically assess data to detect trends and outliers; create and update detailed dashboards and trackers; ensure compliance with SOPs and ethical standards
Seniority
Senior, hands-on IC
