Key skills
LeadershipNegotiation
About this role
Role Overview
- Conduct site monitoring responsibilities for clinical trials
- Provide oversight, leadership, and guidance in the management and execution of clinical trials
- Review monitoring visit reports, conduct co-monitoring and evaluation visits
- Ensure appropriate and timely investigator site visits
- Coordinate with cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues
- Assist in the development of study-specific Monitoring Plans and training presentations
- Manage study budget and act as a referent for the sponsor
- Prepare accurate and timely monitoring visit reports
- Ensure integrity of CRF data and perform quality control
- Review site regulatory binder for required documents
Requirements
- US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
- US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience with 1 year of management experience
- EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and ability to autonomously manage monitoring activities
- US: Permanent authorization to work in the U.S.
- EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
- EU: Graduation in a scientific health field.
- English proficiency required for US
- Local language proficiency required for EU monitoring activities
Benefits
- Professional development
- Global travel
- Flexible work programs