Clinical Affairs Program Manager Spain

Our client is a global medical device company, a pioneer of 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 the successful execution of roadmap clinical trials that demonstrate medical product safety and efficacy. Additional responsibilities include managing clinical trial 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 a clinical management position in the biopharmaceutical or device industry, Clinical Research Organization. Biopharmaceutical experience is a strong advantage
• Additional 4+ years of direct experience in clinical trial management
• Proven track record in successfully executing Phase I – III clinical trials
• Expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines. FDA and / or Health Canada experience is a strong advantage but not required
• Strong, hands-on manager with experience 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, and organizational skills; strong program management and financial skills
• Excellent command of English, both written and verbal; additional languages are a significant advantage
• Collaborative team player with the ability to operate independently
• Willing and able to travel domestically and internationally, up to 40%

Responsibilities :

• Collaborate with company stakeholders to execute objectives into successful clinical trials and investigator-sponsored studies
• Design clinical trials, including protocol development, discussions with EU Competent Authorities, and developing timelines and budgets
• Manage the process of screening, qualifying, selecting, and contracting investigators, sites, and vendors
• Secure necessary approvals from IRBs / ECs and ensure studies are on track for site initiation, patient recruitment, and enrollment; take corrective actions as needed
• Develop budgets for clinical projects and adhere to financial goals
• Interpret and document clinical results clearly for regulatory submissions and publications
• Build and maintain collaborations with stakeholders, investigators, researchers, and key opinion leaders
• Participate in developing SOPs and work instructions to ensure compliance with GCP regulations and standards
• Ensure adherence to protocols and regulatory guidelines (FDA, ICH, ISO, GCP) and SOP procedures
• Identify training needs and develop training materials for internal and clinical site use

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