Job Title: Regulatory Contact for Clinical Studies
We are seeking a highly motivated and experienced professional to join our team as a Regulatory Contact for Clinical Studies.
Job Description
As a Regulatory Contact, you will be responsible for managing the regulatory aspects of clinical studies in Germany, Austria, and Switzerland. This includes:
* Performing local clinical study application submissions
* Preparing and translating submission documents
* Staying up-to-date on local regulatory requirements
* Providing guidance on regulatory requirements
In addition, you may be required to contribute to and coordinate regulatory and EC clinical study application submissions for multi-country trials. If applicable, you will also work partly as a CRA (Clinical Research Associate) including:
* Monitoring and managing clinical trials in compliance with protocol, ICH-GCP/ISO 14155, SOPs, and regulations
* Serving as the main point of contact with the study site
* Performing Source Data Review (SDR), Source Data Verification (SDV), and reviewing Case Report Forms (CRFs)
* Documenting monitoring visits and submitting reports on time
* Handling and distributing study supplies and products
* Setting up site budgets and agreements
* Providing training and developing study materials
Required Skills and Qualifications
To be successful in this role, you will need to possess the following skills and qualifications:
* 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 devices locally and preferably internationally, including the 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
Benefits
We offer a challenging and exciting position in an international environment that values collaboration, sharing of experience, and continuous development of our employees. You will be given meaningful tasks requiring efficient collaboration between industry, clinical, and scientific teams, and the authorities. We also offer a competitive compensation package and great development opportunities for all employees.
Others
All applications will be treated confidentially and will be evaluated when received. Please submit your application in English.