Clinical Trial Manager
Core
Lead the operational execution of clinical studies in Oncology and Rare Disease, ensuring compliance with protocols and regulatory requirements.
Role type
Senior Clinical Trial Manager
Builds
Clinical studies for life sciences companies
Domain
Life Sciences / Clinical Research / Oncology / Rare Disease
Required skills
Clinical trial planning and oversight, Site feasibility and recruitment strategy, Investigator relations, Regulatory submission management, Clinical monitoring strategy, eTMF management, CAPA development, Investigational product accountability, Vendor management, Data quality review
Preferred skills
Advanced degree in science or health-related field, Significant clinical monitoring experience, Line management experience
Technologies
CTMS, Microsoft Office (Outlook, Word, Excel, PowerPoint)
Responsibilities
Serve as primary clinical point of contact with the client, Develop study-related clinical documents and training materials, Generate site lists and drive feasibility processes, Oversee submissions to Competent Authorities and IRBs, Manage clinical monitoring strategies and eTMF, Collaborate on CAPA plans and prepare for GCP audits, Manage investigational product accountability and vendor relationships.
Seniority
Senior, hands-on IC with potential line management
