Clinical Trial Manager- Netherlands
- Experience Level
Upsilon Global are working with a mid-size full service global CRO, with offices in nearly 40 locations worldwide and about 4,000 employees globally.
Our partner works in a number of therapeutic areas like oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective in all phases and their main clients a re bio-pharmas.
They are continuing their growth in their team and they are seeking a clinical trial manager to lead the studies on a European and Global level.
- Manage and provide accountability for day-to-day operations of the project, as defined by the contract and according to ICH/GCP and all other applicable laws, rules, and regulations
- Serve as primary Sponsor contact for operational project-specific issues and study deliverables
- Maintain in depth knowledge of protocol, therapeutic area, and indication
- Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
- Review and provide input for study protocol, edit check specifications, data analysis plan, and final study report, when applicable
- Develop operational project plans
- Manage risk assessment and execution
- Responsible for management of study vendor
- Manage site quality, including direct supervision of project Clinical Research Associates and monitoring deliverables
- Minimum Bachelor’s degree in a health related field; Advanced degree in a health related field preferred
- Experience in Phases 1-4; Phases 2-3 preferred
- Bid-defense experience, preferred
- 3-5 years in project management/clinical trial management in clinical research industry
- Strong leadership skills