Clinical Affairs Program Manager Switzerland
vor 2 Wochen
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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Channel Programs Manager Switzerland
Vor 6 Tagen
CHE - HP Schweiz (Glatt-Tower), Wallisellen, Switzerland HP VollzeitChannel Programs Manager SwitzerlandDescription - We're looking for a motivated Channel Programs Manager Switzerland to support partner onboarding, relationship management, and demand‑generation activities that drive customer acquisition and business growth through partner channels. In this role, you'll help deliver a differentiated customer experience,...
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CLINICAL SALES AND COMMERCIAL DIRECTOR
vor 2 Wochen
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National Sales Manager, Switzerland
vor 2 Wochen
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Clinical Sales Specialist
vor 1 Woche
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Partner Manager IPaaS Switzerland
Vor 5 Tagen
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Process Engineering Manager
vor 2 Wochen
switzerland microTECH Global Ltd VollzeitProcess Engineering Manager – Switzerland Highly competitive salary, plus benefits and relocation support The Process Engineering Section Manager is leading and organizing a process engineering team in order to provide to the production reliable processes, tools and methods to achieve the company target in terms of quality, cost, delivery and technology....
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Strategic Account Executive
vor 2 Wochen
switzerland Datadog VollzeitStrategic Account Executive (Switzerland) Switzerland, Remote Our Strategic Account Executives target and close new business with Datadog’s largest, most strategic customers and prospects. In this role you’ll be focused on uncovering the pain points organizations face as they operate in or migrate to a cloud environment at scale as well as delivering the...
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Senior Clinical Research Associate
vor 2 Wochen
Remote - Europe, EU, Switzerland Anteris Tech VollzeitAnteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart...