Local Regulatory Contact SSU/ Regulatory Lead (Clinical Studies)/ (Sr

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

Contact

Contact Information:

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Trine Dyring, Director Clinical Operations,

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All applications are treated confidentially and will be evaluated when received, so please apply as soon as possible. Please submit your application in English.