Project Manager Clinical Operations (f/m/x)
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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