Local Regulatory Contact SSU/ Regulatory Lead
Vor 2 Tagen
About us As LINK Medical continues to grow, we currently have an open position at our office in Berlin (DE) LINK Medical is searching for a highly motivated Local Regulatory Contact Study Start-Up (SSU)/Regulatory Lead (Clinical Studies)/ (Sr) CRA in Germany. As a Local Regulatory Contact SSU /Regulatory Lead (Clinical Studies), you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas. This role can also be combined with a CRA role. As a CRA you may also be outsourced to clients, and the position will involve frequent travelling related to monitoring visits. Tasks Perform local clinical study application submissions in Germany mainly, but also in Austria and Switzerland. (This includes both medicinal products and medical device studies and interventional as well as non-interventional studies.) Preparation and translation of submission documents (including ICFs). Stay up to date about local regulatory requirements for drug/ device development/ clinical study submissions. Provide guidance (internal and external) on regulatory requirements. Optional (dependent on previous experience): Contribute to and coordinate regulatory and EC clinical study application submissions for multi country trials (including submissions for Clinical Trials with IMPs via CTIS). If applicable also work partly as CRA including: Monitor and manage clinical trials (phases I-IV) in compliance with protocol, ICH-GCP/ISO 14155, SOPs, and regulations. Serve as main point of contact with the study site. Perform Source Data Review (SDR), Source Data Verification (SDV) and review Case Report Forms (CRFs). Document monitoring visits and submitting reports on time. Handle and distribute study supplies and products, when applicable. Set up site budgets and agreements. Provide training and develop study materials. Profile Bachelor's degree or equivalent in a relevant field. Knowledge of ICH-GCP, ISO14155 and national regulations. Experience in clinical trials submissions for both investigational medicinal products and medical device locally and preferably also internationally incl. UK Experience in monitoring clinical studies and site management is preferable, but not a requirement. Fluent in the local language and English. Strong writing and IT skills. We offer LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees in an international environment and values as honest and open communication are essential. You will be given meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams, and the authorities. Besides a great working environment with dedicated and supporting colleagues, we also offer a competitive compensation, benefit scheme and great development opportunities for all employees. Contact Contact Information: If you would like to know more or if you have any questions about the position, please contact: Elin Nilsson, Director Clinical Project Management +46 760 382437, Elin.Nilsson@linkmedical.eu or Trine Dyring, Director Clinical Operations, +45 4127 8470, trine.dyring.jensen@linkmedical.eu All applications are treated confidentially and will be evaluated when received, so please apply as soon as possible. Please submit your application in English.
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