Clinical Trial Manager/Senior Clinical Trial Manager
Core
Lead the operational planning, conduct, and oversight of clinical studies, ensuring compliance with protocols, SOPs, and regulatory requirements while managing site recruitment, vendor oversight, and data quality.
Role type
Senior Clinical Trial Manager (IC with potential line management)
Builds
Clinical studies for pharmaceutical and/or device research
Domain
Clinical Research / Life Sciences
Required skills
ICH-GCP compliance, clinical monitoring strategy, site feasibility and recruitment, vendor management, budget management, regulatory submissions, data quality oversight, risk management, team leadership
Preferred skills
Advanced degree, experience with Radiopharmaceuticals, experience with CAR-T studies
Technologies
CTMS, Microsoft Office (Outlook, Word, Excel, PowerPoint), eTMF
Responsibilities
Develop study documents (ICF, CRF guidelines, training materials), generate site lists and drive feasibility, develop recruitment/retention strategies, oversee IP release and accountability, manage clinical vendors, support GCP audits, generate metric reporting, lead internal team meetings, negotiate site contracts
Seniority
Senior, hands-on IC with potential line management
