Clinical Affairs Program Manager France
il y a 1 semaine
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 disciplines 2) Minimum 3+ years in clinical management position in biopharmaceutical or device industry, Clinical Research Organization. Biopharmaceutical experience would provide a strong advantage 3) Additional 4+ years direct experience in clinical trial management 4) Solid track record in successfully executing Phase I – III clinical trials 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. 6) Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting 7) Knowledge of electronic data capture systems and web-based clinical trial management tools 8) Excellent interpersonal, written / verbal communication, computer & organizational skills, strong program management and financial skills 9) Excellent command of the English language; both written and verbal. Additional language beside native language is a significant advantage 10) Collaborative team player with strong abilities to operate independently 11) 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 budget Manage the process of screening/qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical trials 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 issues Develops budget for all clinical projects and adhere to company financial goals Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications Develop, maintain and expand collaborations with Company Stakeholders, clinical investigators and researchers, and key opinion leaders to optimize the clinical development programs 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 standards Ensure adherence to protocols and compliance with regulatory (FDA/ICH/ISO/GCP) guidelines as well as SOP procedures Identify clinical training needs and develop training materials for in-house and clinical site use
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Clinical Affairs Officer
il y a 1 semaine
France Barrington James Temps plein**Barrington James** is seeking a **Clinical Affairs Officer** to join an innovative and fast-growing medical device organisation. This role offers the opportunity to take ownership of clinical and regulatory activities, making a real impact in the healthcare industry! **Key Responsibilities**: - Conduct **scientific and competitive intelligence**,...
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Associate Director, Medical Affairs, France
il y a 2 jours
France Illumina Temps pleinAssociate Director, Medical Affairs, France page is loaded **Associate Director, Medical Affairs (Genetic Disease Testing & Reproductive Health)** **France - Remote** **Closing date - 16th May** **Th e role** The Associate Director of Medical Affairs will be responsible for strategically developing highly visible research collaborations with prominent...
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Clinical Affairs Intern
il y a 2 semaines
Rue des Vinaigriers, Paris, France Gleamer Temps pleinL'équipe Clinical AffairsL'équipe Clinical Affairs est au cœur de la validation scientifique et recherche clinique autour des produits Gleamer. Elle conçoit, pilote et valorise les études cliniques qui démontrent la performance et l'impact de nos solutions d'intelligence artificielle.MissionsEn tant que stagiaire affaires cliniques, tu seras...
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Clinical Specialist
il y a 2 semaines
France Barrington James Temps pleinA global leader in the sports medicine market and experiencing strong growth, we offer innovative solutions based on cutting-edge technologies. As part of our development, we are recruiting a Clinical Affairs Specialist (M/F).Reporting to the R&D – Clinical Affairs Department, your main responsibilities will include:Scientific and Competitive...
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Clinical Manager – Europe
il y a 1 semaine
Île-de-France Concept Medical Temps pleinDepartment: Clinical TrialsRole SummaryThe Clinical Manager – Europe is responsible for planning, executing, and overseeing clinical trials for coronary and peripheral vascular medical devices across the European region. This role provides strategic and operational leadership to internal teams and external vendors (CROs, core laboratories, investigational...
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Head of Medical Affairs, France
il y a 4 jours
France (Remote) Genmab Temps pleinAt Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are...
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Clinical Data Manager
il y a 3 jours
France i-Pharm Consulting Temps pleinClinical Data Manager – FranceContract | Full-time | RemoteAre you an experienced Clinical Data Manager with a proven track record of leading end-to-end data management activities?We are seeking a Data Management professional to join a dedicated team supporting a critical client project within a global life sciences organisation.This role offers the...
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Medical Science Liaison
il y a 2 jours
France Amplity Health Temps pleinJoin Amplity, the full-service go-to partner of biopharma companies that delivers flexible + specialized medical + commercial services. No matter where a drug is in its lifecycle, we scale with ease to maximize resources + improve impact for all our clients. Through strategic partnerships + deep therapeutic expertise, Amplity transforms how breakthrough...
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Pharmacist: CMC Regulatory Project Manager
il y a 2 jours
France Aixial Group Temps pleinA global Contract Research Organization in Auvergne-Rhône-Alpes, France is seeking a Pharmacist – Technical and Regulatory Project Manager. The role involves managing regulatory projects, drafting Marketing Authorization dossiers, and requires fluency in English and French. Candidates should have a Pharmacy degree and at least 5 years of experience in CMC...
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Clinical Research Associate
il y a 2 jours
France ICON Strategic Solutions Temps pleinICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Clinical Research Associate II to join our diverse and dynamic team. As...
