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

Ihr ZEISS Recruiting Team:

Celine Karbach