Project Manager Clinical Operations

vor 1 Monat


Berlin, Deutschland ZEISS Gruppe Vollzeit

Your Role

  • Development of study protocols in coordination with the Clinical Affairs Manager as well as with Clinical Partners
  • Define test methods according to state of the art or relevant guidelines and ensure availability of required devices
  • Selecting and coordinating with national and international study sites and service providers; establishing long-term clinical partnerships with international study sites
  • Drafting contracts with clinical partners in coordination with the legal department including negotiation of investigator fees
  • Preparation and submission of applications for approval of clinical studies to authorities and ethics committees.
  • Organization and execution of clinical studies with coordination of all parties involved for planning and meeting timelines, milestones and budgets, reporting on project progress, preparing presentations to management on project/study results
  • Identify and assess risks and challenges and derive appropriate preventive and corrective measures. Monitor success of measures used
  • Responsibility for completeness and quality of essential study documents and appropriate archiving thereof
  • Manage statistical analysis plan, statistical analysis and evaluation of clinical results analysed and preparation of study reports. Contribute to / review scientific publications, develop and define standard treatment recommendations and indication statements in collaboration with the CA manager.
  • Review and evaluate new regulations, guidelines, standards for clinical studies; derive measures and adapt existing clinical affairs process descriptions

Your Profile

  • Minimum four-year college/university degree in optometry/optometry, medicine, medical technology or natural sciences Work experience
  • Long term experience in clinical affairs/clinical research project management in the medical device/ pharma industry or with contract research organizations
  • In-depth knowledge of relevant regulatory requirements for clinical studies and clinical evaluations for medical devices (ICH-GCP, ISO 14155, MDR, MPDG, MDCG, MEDDEV, IMDRF guidelines) and experience in planning and conducting clinical studies with proven success. Other knowledge
  • Good knowledge of biostatistics, data management and regulatory requirements for CE, FDA, NMPA, Health Canada, etc. and clinical evaluations
  • Demonstrated qualities in project management with external service providers/vendors, e.g., contract research organizations
  • Strong analytical skills coupled with creativity and intuition
  • Commitment and creative drive as well as strong communication and organizational skills in an international environment
  • Very good oral and written communication in and English
  • Willingness to travel worldwide

Your ZEISS Recruiting Team:
Celine Karbach


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