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:
- BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines
- Minimum 3+ years in clinical management position in biopharmaceutical or device industry, Clinical Research Organization. Biopharmaceutical experience would provide a strong advantage
- Additional 4+ years direct experience in clinical trial management
- Solid track record in successfully executing Phase I – III clinical trials
- 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.
- Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting
- Knowledge of electronic data capture systems and web-based clinical trial management tools
- Excellent interpersonal, written / verbal communication, computer & organizational skills, strong program management and financial skills
- Excellent command of the English language; both written and verbal. Additional language beside native language is a significant advantage
- Collaborative team player with strong abilities to operate independently
- 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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