Clinical Project Leader Nr ref.: /JOBS.pl Key People are looking for a Clinical Project Leader to work for our biotech client based in the Munich area focusing on global trialsMain Responsibilities:• Plan, implement and supervise clinical trials, working in close collaboration with project leaders, clinical research physicians and other stakeholders • Oversee execution of one or more clinical trial, while ensuring that all trial deliverables are met according to specified timelines, budgets, and quality including CRO selection and management • Define, negotiate and ensure execution of study-related agreements with investigational sites, CROs, Central Lab Services etc. • Contribute to preparation of clinical program documents, e.g. investigator brochure, IND annual report, health authority submissions etc. • Develop study-related documents from concept sheets to final documents and ensure resolution of critical issues• Identify areas of best practice and contribute to process improvement• Line Management of assigned staff Minimum Requirements:• Minimum of three years' professional experience in multinational clinical trial management, focusing on the pharmaceutical or biotech industry • Proven track record of compiling clinical study protocols, reports and publications • Demonstrable expertise relating to all aspects of the clinical development process• Ability to identify and resolve complex methodological issues relating to clinical trials• Well-developed organizational and interpersonal skills, complemented by attention to detail • Good knowledge of GCP and regulatory requirements (especially FDA and EMA) • Fluent written and spoken English • Willingness to travel (approx. 25%) Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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