Clinical affairs program manager switzerland

Ppb Job Description /b /p /p pOur 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. /p pAs 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. /p pRequired Skills and Experience:br/ 1) BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplinesbr/ 2) Minimum 3+ years in clinical management position in biopharmaceutical or device industry, Clinical Research Organization. Biopharmaceutical experience would provide a strong advantagebr/ 3) Additional 4+ years direct experience in clinical trial managementbr/ 4) Solid track record in successfully executing Phase I – III clinical trialsbr/ 5) 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.br/ 6) Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reportingbr/ 7) Knowledge of electronic data capture systems and web-based clinical trial management toolsbr/ 8) Excellent interpersonal, written / verbal communication, computer organizational skills, strong program management and financial skillsbr/ 9) Excellent command of the English language; both written and verbal. Additional language beside native language is a significant advantagebr/ 10) Collaborative team player with strong abilities to operate independentlybr/ 11) Willing able to travel domestically and internationally, as required (up to 40%) /p pResponsibilities:br/ Collaborate with Company Stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, etc.br/ Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with EU Competent Authorities, and development of timeline and budgetbr/ Manage the process of screening/qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical trialsbr/ Direct/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 issuesbr/ Develops budget for all clinical projects and adhere to company financial goalsbr/ Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publicationsbr/ Develop, maintain and expand collaborations with Company Stakeholders, clinical investigators and researchers, and key opinion leaders to optimize the clinical development programsbr/ Participate 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 standardsbr/ Ensure adherence to protocols and compliance with regulatory (FDA/ICH/ISO/GCP) guidelines as well as SOP proceduresbr/ Identify clinical training needs and develop training materials for in-house and clinical site use /p