Clinical Trial Manager, Clinical Operations
Core
Independently lead operational execution of global clinical trials (Phase I–IV) for a biopharmaceutical company's novel therapeutics targeting metabolic dysfunction-associated steatohepatitis (MASH).
Role type
Senior Clinical Trial Manager (Clinical Operations)
Builds
Global clinical studies for MASH therapeutics
Domain
Biopharmaceuticals / Clinical Operations / Hepatology
Deliverable
client delivery
Required skills
Clinical trial operations leadership, ICH-GCP compliance, CRO/vendor management, study lifecycle management, risk mitigation, project management, regulatory inspection readiness, budget oversight, mentorship
Preferred skills
Early-phase/registrational study experience, global clinical trial experience, therapeutic area experience (metabolic disease, hepatology, cardiovascular)
Technologies
CTMS, eTMF, EDC, IRT, Microsoft Office Suite
Responsibilities
Lead day-to-day operational management of assigned global clinical trials; Coordinate clinical trial start-up, maintenance, close-out, and inspection readiness; Develop and finalize key study documentation including protocols and operational manuals; Lead operational oversight of CROs and vendors; Monitor study enrollment, subject tracking, and data quality metrics; Mentor Associate Clinical Trial Managers and Clinical Trial Specialists.
Seniority
Senior, hands-on IC with mentorship responsibilities
