Description
We are looking for a
Clinical Project Manager/Senior CRA (in-house) (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM+
Ort: in Bavaria
Branche: Sonstige Forschung und Entwicklung im Bereich Natur-, Ingenieur-, Agrarwissenschaften und Medizin
Ihre Aufgaben:
- Plan, implement and supervise clinical trials (close collaboration with project leaders, clinical research physicians etc.)
- Support of the project leader so that clinical trials are monitored
- Responsibility for organizational tasks such as budgeting, CRO management, (management of) co-monitoring
- Oversee execution of one or more clinical trials, while ensuring that all trial deliverables are met according to specified timelines, budgets, resources etc.
- Responsibility for study-related documents such as Clinical Trial Agreements, CROs, Central Lab Services, investigator brochure, IND annual report, health authority briefing books and submissions
- Establishment and management of the study plan
Ihre Qualifikation
- Professional experience in trial management (multinational) with up-to-date knowledge of GCP and regulatory requirement according to EMEA and FDA standards
- Experience with preparing summaries of clinical study protocols, reports and publications
- Advanced organizational and interpersonal skills and a personality that pays attention to details
- Very good communication and presentation skills
- Willingness to travel to a slight extent
Skills:
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- Clinical trial manager