Clinical Trial Manager

About the role

The Clinical Trial Manager is responsible for leading the planning, execution, oversight, and delivery of early phase clinical trials.

What you'll do

• Lead the operational execution of assigned domestic or global early phase clinical trial(s) including oversight of selected vendor(s)/CRO to ensure accountability
• Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans to ensure delivery on timeline and financial goals are met
• Initiate and manage request for proposal activities for assigned clinical studies or clinical development vendors, including CROs, specialty lab vendors
• Lead study execution team comprised of cross-functional representatives from Regulatory, Drug Safety, Medical, Drug Supply, Data Management, Biostatistics
• Manage clinical development vendors according to vendor oversight plans

What you need

• 10–18 yrs of experience
• Clinical research
• Pharmacovigilance
• GMP
• Regulatory affairs
• CRO
• Documentation
• B.Sc or B.Tech or B.E. or BCA

Good to have

• SOP writing
• GCP
• Data privacy