Clinical Trial Manager
Core
Lead the operational execution of clinical studies, ensuring compliance with protocols and regulations while managing site recruitment, data quality, and vendor oversight.
Role type
Senior Clinical Trial Manager (Oncology/Rare Disease)
Builds
Clinical trials for life sciences therapies
Domain
Life Sciences / Clinical Research / Oncology
Deliverable
client delivery
Required skills
Clinical trial planning and oversight, site feasibility and recruitment strategy, regulatory compliance (ICH-GCP), clinical monitoring strategy, data quality management, vendor management, budget variance management, CAPA implementation, GCP audit preparation
Preferred skills
Advanced degree in science or health-related field, Phase 1 FIH and healthy volunteer trial experience, Mandarin proficiency
Technologies
CTMS, eTMF, Microsoft Office (Outlook, Word, Excel, PowerPoint)
Responsibilities
Serve as primary clinical point of contact with clients; develop study documents and training materials; generate site lists and drive feasibility; develop recruitment/retention strategies; oversee IP release and accountability; manage submissions to Competent Authorities and IRBs; generate metric reporting; manage clinical vendors; support business development activities; negotiate site budgets and contracts; perform clinical data review
Seniority
Senior, hands-on IC with potential line management responsibilities
