Clinical Operations Lead - Budapest
- Experience Level
Upsilon Global are working with an award winning mid-size global CRO that is present in over 35 locations globally and work in a number of therapeutic areas like oncology, CNS, cardiology, metabolic diseases and anti-infective in all phases.
They are seeking a Clinical Operations Lead to join their team in Budapest in the clinical operations team.
The CRO offers great continuous career development and training and has been named one of the top work place by their employees globally.
Below are the responsibilities you will have as a Clinical Operations Lead:
- 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
Qualifications and experience:
- 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