Clinical Affairs Program Manager Europe

2 weeks ago


Vernon, Texas, United States Chronos Consulting Full time
Job Description

Our client is a pioneering medical device company that has revolutionized the field of MR-guided focused ultrasound technology. As a Clinical Affairs Program Manager Europe, you will play a crucial role in the global clinical affairs team, responsible for developing strategies for the successful execution of clinical trials that demonstrate medical product safety and efficacy.

Key Responsibilities:
  • Develop and implement clinical trial strategies to ensure compliance with regulatory guidelines and company objectives.
  • Manage the process of screening, qualifying, and selecting investigators, sites, and vendors for clinical trials.
  • Collaborate with company stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, and other research initiatives.
  • Develop and maintain relationships with clinical investigators, researchers, and key opinion leaders to optimize clinical development programs.
  • Ensure adherence to protocols and compliance with regulatory guidelines, as well as SOP procedures.
Requirements:
  • BS, BA, BSN, or RN degree in Life Sciences or related disciplines.
  • Minimum 3+ years of experience in clinical management positions in biopharmaceutical or device industries, Clinical Research Organizations, or related fields.
  • Additional 4+ years of 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.
  • Strong, hands-on management skills with experience in managing Core Labs, data management, biostatistics, and medical safety reporting.
  • Excellent interpersonal, written, verbal communication, computer, and 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.
  • Will and able to travel domestically and internationally, as required (up to 40%).


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