Clinical Development Manager (BB-4FBF0)
Gefunden in: Xpatjobs CH
Beschreibung:Lead the delivery of clinical development activities defining Clinical Programs and for regulatory approvals in a successful lifecycle management.Supervise clinical study teams in development and conduct of defined clinical studies on time and within budget.Ensure consistency with clinical development strategy and KPIs in place.Assures clinical studies are conducted effectively in partnership with Marketing / Regulatory RD Department, and CRO as appropriate.Lead the preparation of regulatory documents and clinical elements of regulatory submission documents.Hands on management and supervision of essential documents development (clinical study protocol, patient consent, Investigator Brochure, Clinical study report) in compliance with the GCPs, the regulations in force and the company''s procedures.Define and Develop clinical /scientific content for publications/ medical and clinical training material. In line with Marketing team, represent the clinical department when exchanging with KOLs, HCPs or during congresses and/or "Advisory boards".Represent the Clinical Development department during audits/exchanges with the health authorities.A minimum of 10 years experience in clinical research in the pharma or medical devices industryMinimum M.Sc. degree in relevant scientific discipline e.g. Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science,Ability of strategic planningResult oriented / Ability to navigate complex data and challenging situations to work through effective solutionsFluency in EnglishExcellent communication skills orally or in written (strong presentation skills)Great opportunity to join a fast growing and dynamic organisation.
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