Clinical Affairs Program Manager Italy
1 settimana fa
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 Program Manager Italy
2 settimane fa
italy Chronos Consulting A tempo pienoJob 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...
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Clinical Trial Manager
3 settimane fa
Italy Advanced Clinical A tempo pienoClinical Trial Manager – Italy | Advanced Clinical (FSP Model) Oncology focused Advanced Clinical is seeking an experienced Clinical Trial Manager to join our UK-based Functional Service Provider (FSP) team. This role will support global clinical studies and requires strong operational, vendor management, and monitoring oversight experience....
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Clinical Trial Manager
3 settimane fa
Turin, PIEDMONT, Italy, Provincia di Torino Advanced Clinical A tempo pienoClinical Trial Manager – Italy | Advanced Clinical (FSP Model) Oncology focused Advanced Clinical is seeking an experienced Clinical Trial Manager to join our UK-based Functional Service Provider (FSP) team. This role will support global clinical studies and requires strong operational, vendor management, and monitoring oversight experience....
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Clinical Vendor Manager
2 giorni fa
Milan, Italy (ITALY, ) IQVIA A tempo pienoOn behalf of our Client a global pharmaceutical company, IQVIA is looking for Vendor Management Lead, Drug Development.The profile will be responsible for selection, contracting, oversight, and performance management of external vendors and collaborators based in Italy, supporting clinical development. External vendors include CROs, CMOs, central labs and...
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Head of Regulatory Affairs and Quality Assurance
2 settimane fa
italy Guided Solutions A tempo pienoOur client is a clinical-stage R&D company that is developing an innovative treatment for solid tumour oncology. We are looking for an experienced medical device Regulatory Affairs and Quality Assurance (QA) professional to join the team in this executive role. The role manages the QA Director and reports to the CEO of the company. PLEASE NOTE the role is...
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Clinical Research Associate
3 settimane fa
Verona, Veneto, Italy, Veneto Barrington James A tempo pienoFreelance Clinical Research Associate (CRA) – Cardiology Medical Devices 12-Month Freelance Contract (Direct with Sponsor) Location: Italy (must be based in Italy) Start Date: ASAP About the Role We are seeking an experienced Freelance Clinical Research Associate (CRA) with a strong background in cardiology medical devices to support a high-priority...
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Clinical Application Specialist, MIS, Italy
3 giorni fa
Rome, Italy| Naples, Italy| Bari, Italy Mindray Medical A tempo pienoClinical Application Specialist, MIS, ItalyLocation: Rome, Italy| Naples, Italy| Bari, Italy(Located in Central or South Italy. Covering all Italian regions.) Field-based, frequent travel in ItalySalary: Highly Competitive + Outstanding Benefits + Fast-Track Career Growth Ready to make a real impact in healthcare?Due to business success and expansion of...
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Clinical Trial Manager
5 giorni fa
Italy-Remote Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...
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italy Chronos Consulting A tempo pienoJob Description Our client is a fast-growing, global medical device company focusing on non-invasive treatments for some of the most challenging diseases for the past 2 decades. The overall goal is to help drive commercial utilization at new and existing customers. The purpose of this role is to increase the number of patients treated to reach business...
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Clinical Site Contract Specialist
4 settimane fa
Rome, Latium, Italy, IT SEC Life Sciences A tempo pienoClinical Site Contract Specialist 6-Month Contract | 0.5 FTE (Part-Time) Europe (Italy & UK Focus) About the Role We are seeking an experienced Clinical Site Contract Specialist to support contract and budget negotiations for clinical trial sites across Italy and the UK. This part-time role involves direct responsibility for preparing, negotiating, and...
