Clinical Trial Manager

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CureVac

Assisting in identification, selection and hiring of appropriate CROs and third-party vendors and support third-party vendor training on protocols and practices
Support of identifying, selecting, and monitoring performance of investigational sites for clinical trials including negotiation and management of investigational site payments
Overseeing performance of CROs, third-party vendors, and field CRAs including co-monitoring to ensure compliance with study protocol; identifying areas of concern and escalating to CPM
Preparing and supporting investigator meetings
Reviewing key study quality metrics (e.g. eligibility, primary endpoint data etc.) and determining appropriate action in conjunction with study team
Tracking and reporting on study progress including site activation, subject/patient enrollment, monitoring visits, and relevant documents
Writing or contributing to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research-related documents

Master´s degree in Life Sciences, otherwise equivalent education and work experience required
5 years experience in clinical research (at CRO and/or sponsor organization) with at least 2 years experience in on-site monitoring of interventional clinical trials (preferably oncology and/or vaccine trials)
At least 1 year of trial management experience
Solid knowledge of clinical study processes, Good Clinical Practice (GCP) and other regulatory guidelines
Basic knowledge of project management and clinical research budgets, including processing and tracking of site and vendor payments, would be an advantage
The ability to support several projects simultaneously, a flexible working style and attention to detail are essential
Strong knowledge of MS Office and MS Project
Fluency in English, German is a plus
Willingness to travel up to 15%

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