Key skills
Leadership
About this role
Role Overview
- Provides operational leadership throughout the study lifecycle
- Oversees and executes study management and site management
- Maintains expertise within their assigned Therapeutic Area
- Drives operational deliverables
- Approves and oversees drug supply management
- Ensures vendor oversight for vendors managed by SOMs
- Develops and reviews study startup, study monitoring, protocol recruitment, and training plans
Requirements
- Exceptional knowledge of study management processes and deliverables
- Study management/leadership experience
- Experience with oversight of CROs and vendors
- Fluency in written and spoken English required
- Ability to work outside of core business hours, as required, to support global trials or initiatives
- Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
- Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required
- Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required
- A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology
Benefits
- N/A