Project Manager Clinical Operations

vor 4 Wochen


Munich, Deutschland ZEISS Group 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

  • Munich, Deutschland Medpace, Inc. Vollzeit

    Job Summary: Due to continuous business growth and a strong study pipeline, we are currently looking to hire Project Coordinators to join our successful and growing German team and engage in clinical trial management on a day-to-day level. This position will work with our operational teams to accomplish tasks and projects that are instrumental to the...


  • Munich, Deutschland Progressive Recruitment NL Vollzeit

    Sie haben Erfahrung als Clinical Project Assistant/ Specialist (CTA) und sind auf der Suche nach einem neuen spannenden Projekt? Dann dürfte folgende Stelle sehr interessant für Sie sein: **Clinical Project Assistant (Freelance)** Ihre künftigen Aufgaben: - Enge Zusammenarbeit bzw. Unterstützung des Clinical Operations Teams hinsichtlich der Planung...


  • Munich, Deutschland Proclinical Vollzeit

    Proclinical are recruiting an Associate Director, Clinical Operations - Infectious Diseases for a biotech organisation. This role is on a permanent basis and is located in Germany. The client is focused on translating science. **Responsibilities**: - Accountable for guaranteeing study timelines are per plan or mitigations are introduced to limit timeline...


  • Munich, Deutschland Alira Health Vollzeit

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...


  • Munich, Deutschland Allucent Vollzeit

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Project Manager (Sr. PM) to join our A-team (hybrid*/remote). As a Sr. PM at Allucent, you are responsible for the overall...


  • Munich, Deutschland Allucent Vollzeit

    At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Project Manager (Sr. PM) to join our A-team (hybrid*/remote). As a Sr. PM at Allucent, you are responsible for the...


  • Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    The Senior Director, Global Clinical Operations (GCO) Europe, is accountable for providing leadership and operational expertise into execution of Resarch & Development (R&D) studies conducted in Europe. The role will be part of the Global Clinical Operations (GCO) group in R&D. This position is expected to: - Collaborate with Contract Research Organization...


  • Munich, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

    With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading...


  • Munich, Deutschland ZEISS Group Vollzeit

    We offer- Modern technology stack - with room for you to try things out in a high-tech group- Munich based job with 40-60% hybrid work- Excellent teammates and a lead to support your development from day one onward. Your Role- Establish and manage clinical research collaborations with clinical partners- Setup collaborations with hospitals and clinics...


  • Munich, Deutschland DEKRA Arbeit GmbH Vollzeit

    As one of the most successful and innovative personnel service companies in Germany, we are looking for a full-time **Assistant Clinical Operation (M/F/d)** for our renowned clients in Munich with immediate effect. **Tasks**: Global and European Lifecycle Project Support - Finance (90%) - Manage all departmental financial projects related tasks by tracking,...


  • Munich, Deutschland DEKRA Arbeit GmbH Vollzeit

    As one of the most successful and innovative personnel service companies in Germany, we are looking for a full-time **Assistant Clinical Operation (M/F/d)** for our renowned clients in Munich with immediate effect. **Tasks**: Global and European Lifecycle Project Support - Finance (90%) - Manage all departmental financial projects related tasks by tracking,...


  • Munich, Bayern, Deutschland NonStop Consulting Vollzeit

    our client is specialise in imaging technology who know work as a cro for develop and process different clinical study. They are now looking for a Clinical Study Manager to join their dynamic and friendly team. As an international position in a human-sized company, this role offers a position where you can develop your career with internal career development...


  • Munich, Bayern, Deutschland NonStop Consulting Vollzeit

    our client is specialise in imaging technology who know work as a cro for develop and process different clinical study. They are now looking for a Clinical Study Manager to join their dynamic and friendly team. As an international position in a human-sized company, this role offers a position where you can develop your career with internal career development...


  • Munich, Deutschland Clinical Trial and Consulting Services Vollzeit

    **Job Purpose/Summary** As a CRA in Homeoffice you will be responsible for the successful conduct of clinical trials and serve as main contact for the investigative site by representing CTI in a professional manner. **What You’ll Do** - Conduct evaluation, initiation, monitoring and close out visits - Assist with regulatory and study start-up activities...


  • Munich, Deutschland NonStop Consulting Vollzeit

    our client is specialise in imaging technology who know work as a cro for develop and process different clinical study. They are now looking for a Clinical Study Manager to join their dynamic and friendly team. As an international position in a human-sized company, this role offers a position where you can develop your career with internal career development...


  • Munich, Bayern, Deutschland ZEISS Gruppe Vollzeit

    Your role Participate in complex project product development with R&D and PM, identify potential clinically relevant issues emerging from (absence of) features and their clinical consequences, define and implement the appropriate clinical evaluation strategy and necessary clinical studies for the product Responsibility for budget and time planning for the...


  • Munich, Deutschland Argenta Vollzeit

    KLIFOVET GmbH, part of the Argenta Group, is a globally recognized supplier in the veterinary and feed sector based in Munich. We have made it our mission to competently accompany customers from the idea, through development, to approval and beyond. The service for our customers determines our actions. Since our founding in 1997, we have been awarded three...


  • Munich, Deutschland Argenta Vollzeit

    KLIFOVET GmbH, part of the Argenta Group, is a globally recognized supplier in the veterinary and feed sector based in Munich. We have made it our mission to competently accompany customers from the idea, through development, to approval and beyond. The service for our customers determines our actions. Since our founding in 1997, we have been awarded three...


  • Munich, Deutschland Alexion Pharmaceuticals,Inc. Vollzeit

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...

  • AD Project Manager

    vor 4 Wochen


    Munich, Deutschland Thermo Fisher Scientific Vollzeit

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...