Clinical Project Manager - Italy
- Experience Level
- Experienced (non-manager)
Upsilon Global are working with a global CRO who are headquartered in the US and have 3,000 + employees in over 30 countries globally. As a full service CRO they work in both drug studies in all Phases and medical devices in various therapeutic areas that include oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective working in partnership with mainly biotech's.
The CRO has over 25 years of experience working in the clinical research field and pride themselves to have been awarded 1st Place in the CRO quality award and CRO awards in leadership.
They offer great opportunities for career growth and continuous development.
This opportunity could be homebased or office-based dependant on location and experience. The role would be part of the Clinical Trial Management team in Italy
- 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
- 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
- 5+ years as a project/clinical trial manager within a CRO
- Management of overall project timeline
- Bid defense experience, preferred
- Strong leadership skills
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