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Clinical Operations Project Leader

vor 2 Monaten


Munich, Bayern, Deutschland ZEISS Group Vollzeit

Your Role

  • Collaborate with the Clinical Affairs Manager and Clinical Partners to develop comprehensive study protocols.
  • Establish test methodologies in accordance with current standards and ensure the necessary equipment is accessible.
  • Identify and manage relationships with both national and international study sites and service providers, fostering long-term clinical collaborations.
  • Coordinate with the legal department to draft and negotiate contracts with clinical partners, including investigator compensation.
  • Prepare and submit applications for clinical study approvals to regulatory bodies and ethics committees.
  • Oversee the organization and execution of clinical studies, ensuring all parties adhere to timelines, milestones, and budgets, while providing regular project updates and presentations to management.
  • Identify potential risks and challenges, implementing appropriate preventive and corrective actions, and monitoring their effectiveness.
  • Ensure the completeness and quality of essential study documentation and maintain proper archiving practices.
  • Manage the statistical analysis plan and the evaluation of clinical results, contributing to the preparation of study reports and reviewing scientific publications.
  • Stay informed on new regulations and guidelines relevant to clinical studies, adapting existing processes as necessary.

Your Profile

  • A minimum of a four-year degree in optometry, medicine, medical technology, or natural sciences.
  • Extensive experience in clinical affairs or clinical research project management within the medical device or pharmaceutical sectors, or with contract research organizations.
  • Thorough understanding of regulatory requirements for clinical studies and evaluations for medical devices, with a proven track record in planning and executing successful clinical studies.
  • Solid knowledge of biostatistics, data management, and regulatory standards for CE, FDA, NMPA, Health Canada, and clinical evaluations.
  • Demonstrated project management skills when working with external service providers and vendors.
  • Strong analytical abilities complemented by creativity and intuition.
  • Commitment to excellence, with strong communication and organizational skills in a global context.
  • Proficient in both oral and written English communication.
  • Willingness to travel internationally as required.

Your ZEISS Recruiting Team:

Celine Karbach