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Clinical Project LeaderRef: 1408-107

Salary:€78000 - €80000 per annum + Bonus + Relocation

Added:19 Jun 2017

Region: Germany

Sector: Pharmaceutical

Sub Sector: Clinical Research

Key People are looking for a Clinical Project Leader to work for our biotech client based in the Munich area focusing on global trials Main 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%)

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