Senior Clinical Trial Manager
Core
Plans and manages overall activities for assigned global clinical trials, ensuring compliance with regulatory requirements and ICH/GCP guidelines.
Role type
Senior Clinical Trial Manager
Builds
Global clinical trials for dermatology products
Domain
Biopharmaceuticals / Dermatology
Required skills
Clinical trial management, CRO oversight, regulatory compliance (ICH/GCP), budget and timeline management, cross-functional team leadership, risk mitigation, protocol development to study reporting
Preferred skills
Drug development process knowledge, biologics experience, GMP/GDP knowledge, major market experience (US, China)
Technologies
Clinical trial management systems, regulatory submission tools
Responsibilities
Lead cross-functional Clinical Trial Team to meet deliverables, establish project milestones and budgets, manage clinical trial progress and documentation, oversee Clinical Research Associates and Administrators, collaborate with CROs and FSPs, prepare for regulatory inspections, contribute to process improvement initiatives
Seniority
Senior, hands-on IC with leadership potential