Clinical Trial Manager (Contract to Perm)
Core
Manage clinical trials from start-up to close-out, ensuring compliance with GCP and regulatory guidelines while delivering on time and within budget.
Role type
Senior Clinical Trial Manager (Phase 1/2)
Builds
Clinical trials for functional antibodies targeting immunological and inflammatory disorders
Domain
Biotechnology / Precision Medicine / Immunology
Required skills
Clinical trial operations management, vendor and CRO management, site feasibility and selection, protocol adherence monitoring, data quality monitoring, regulatory compliance (GCP/ICH/FDA), recruitment strategy, stakeholder communication
Preferred skills
Phase 1/2 trial experience, recruitment and retention tactics, site relationship management, biotechnology environment experience
Technologies
GCP, ICH guidelines, FDA regulations, ECG, central imaging, central laboratories
Responsibilities
Manage trial timelines, scope, budget, and quality; oversee site selection and investigator relationships; monitor data quality and resolve deviations; ensure regulatory compliance and SAE reporting; manage CROs and clinical vendors; prepare status reports on recruitment, site performance, and safety.
Seniority
Senior, hands-on IC