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Project Manager Clinical Operations

vor 4 Monaten

Jena Berlin München Oberkochen, DE ZEISS Vollzeit
Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.

In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Apply now It takes less than 10 minutes.

Aufgaben

  • 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


Profil

  • 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


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