Clinical Affairs Program Manager Netherlands
Job Description Our client is a global medical device company, a pioneer of the MR-guided focused ultrasound technology which is a game-changing innovation. They are looking for a Clinical Affairs Program Manager Europe. The role is % remote with up to 40% travel and based in Europe.As part of the global clinical affairs team, you will be responsible for developing strategies for a successful execution of roadmap clinical trials that demonstrate medical product safety and efficacy. Additional responsibilities include management of clinical trials approvals with local IRBs and/or Competent Authorities.Required Skills and Experience:1) BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines2) Minimum 3+ years in clinical management position in biopharmaceutical or device industry, Clinical Research Organization. Biopharmaceutical experience would provide a strong advantage3) Additional 4+ years direct experience in clinical trial management4) Solid track record in successfully executing Phase I – III clinical trials5) Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines. Additional FDA and or Health Canada experience would provide a strong advantage but will not be required.6) Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting7) Knowledge of electronic data capture systems and web-based clinical trial management tools8) Excellent interpersonal, written / verbal communication, computer & organizational skills, strong program management and financial skills9) Excellent command of the English language; both written and verbal. Additional language beside native language is a significant advantage10) Collaborative team player with strong abilities to operate independently11) Willing & able to travel domestically and internationally, as required (up to 40%)Responsibilities:Collaborate with Company Stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, etc.Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with EU Competent Authorities, and development of timeline and budgetManage the process of screening/qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical trialsDirect/Manage necessary clinical trial approvals from IRBs/ECs, and ensure studies are on track for site initiation, patient recruitment and enrollment; take corrective actions where necessary to address issuesDevelops budget for all clinical projects and adhere to company financial goalsEnsure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publicationsDevelop, maintain and expand collaborations with Company Stakeholders, clinical investigators and researchers, and key opinion leaders to optimize the clinical development programsParticipate in the development of SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standardsEnsure adherence to protocols and compliance with regulatory (FDA/ICH/ISO/GCP) guidelines as well as SOP proceduresIdentify clinical training needs and develop training materials for in-house and clinical site use
Clinical Affairs Program Manager Netherlands
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