Clinical Trials Manager
Core
Drive end-to-end operational delivery of Phase II and III oncology clinical trials, ensuring high-quality execution through cross-functional leadership and CRO/vendor oversight.
Role type
Senior Clinical Trials Manager (Oncology)
Builds
In-house and/or hybrid model clinical trials for oncology pipeline
Domain
Biopharma / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, clinical trial operations, regulatory compliance (FDA/EMEA/GCP), CRO/vendor management, study timeline management, budget development, protocol development, data review and reporting
Preferred skills
Knowledge of ICH guidelines, experience with site evaluation and initiation/close-out visits, training of CROs and investigators
Technologies
Clinical trial management systems (CTMS), electronic data capture (EDC), regulatory document management tools
Responsibilities
Coordinate and supervise all aspects of clinical study execution; Provide input into study protocols, investigator brochures, case report forms, and informed consents; Maintain study timelines and documentation; Contribute to study budget and RFP development; Manage CROs/vendors and oversee site visits; Ensure regulatory compliance and SOP adherence; Coordinate review of data listings and preparation of interim/final clinical study reports; Develop tools to optimize project efficiencies
Seniority
Senior, hands-on IC