Jobs in Treviso, United States

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14.06.2025

29.07.2025

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Job Description

Our client is a global medical device company, pioneer of MR-guided focused ultrasound technology, a game-changing innovation. They are seeking a Clinical Affairs Program Manager for Europe. The role is primarily remote, with up to 40% travel, based in Europe.

As part of the global clinical affairs team, you will develop strategies for executing clinical trials that demonstrate the safety and efficacy of medical products. Responsibilities also include managing clinical trial approvals with local IRBs and/or Competent Authorities.

Required Skills and Experience:

1. BS, BA, BSN, RN, or higher degree in Life Sciences or related fields
2. At least 3 years in clinical management within biopharmaceutical, device industry, or CRO, with biopharmaceutical experience being a strong advantage
3. Over 4 years of direct experience in clinical trial management
4. Proven success in Phase I–III clinical trials
5. Expertise in GCP, ICH, ISO guidelines; FDA or Health Canada experience is a plus but not required
6. Experience managing Core Labs, data management, biostatistics, and safety reporting
7. Knowledge of electronic data capture and clinical trial management systems
8. Excellent communication, organizational, program management, and financial skills
9. Proficiency in English; additional languages are a plus
10. Ability to work independently and collaboratively
11. Willingness to travel up to 40% domestically and internationally

Responsibilities:

• Collaborate with stakeholders to execute clinical trials and investigator-sponsored studies
• Design clinical trials, including protocol development and discussions with EU authorities
• Manage investigator and vendor selection, contracting, and clinical trial approvals
• Develop budgets and ensure adherence to financial goals
• Interpret and document clinical results for regulatory submissions and publications
• Build and maintain relationships with investigators, researchers, and key opinion leaders
• Develop SOPs and work instructions to ensure compliance with GCP and other standards
• Ensure protocol adherence and regulatory compliance
• Identify training needs and develop training materials for staff and sites