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Clinical Operations Project Manager

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 line with contemporary standards and ensure the necessary equipment is accessible.
  • Identify and manage relationships with both national and international study sites and service providers, fostering enduring clinical partnerships.
  • Coordinate with the legal department to draft and negotiate contracts with clinical partners, including investigator fee agreements.
  • Prepare and submit clinical study applications for approval to regulatory authorities and ethics committees.
  • Oversee the organization and execution of clinical studies, ensuring all parties are aligned with planning, timelines, milestones, and budgets, while providing progress reports and presentations to management.
  • Evaluate risks and challenges, implementing suitable preventive and corrective actions, and monitor the effectiveness of these measures.
  • Ensure the completeness and quality of essential study documentation and manage proper archiving practices.
  • Oversee the statistical analysis plan and the evaluation of clinical results, preparing detailed study reports and contributing to scientific publications, as well as developing treatment recommendations in collaboration with the Clinical Affairs Manager.
  • Review and interpret new regulations, guidelines, and standards related to clinical studies, adapting existing clinical affairs processes accordingly.

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 industry, or with contract research organizations.
  • Thorough understanding of regulatory requirements for clinical studies and evaluations for medical devices, including ICH-GCP, ISO 14155, MDR, MPDG, MDCG, and IMDRF guidelines, with a proven track record in planning and executing successful clinical studies.
  • Solid knowledge of biostatistics, data management, and regulatory requirements for CE, FDA, NMPA, and Health Canada.
  • Proven project management skills with external service providers and vendors.
  • Strong analytical capabilities combined with creativity and intuition.
  • Demonstrated commitment, innovative thinking, and excellent communication and organizational skills in a global context.
  • Proficient in both oral and written English communication.
  • Willingness to travel internationally.

Your ZEISS Recruiting Team:

Celine Karbach