Local Regulatory Contact SSU / Regulatory Lead (ClinicalStudies) / (Sr) CRA at LINK Medical (DE)

Link Medical; Berlin; Vor Ort; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A European Clinical Research Organization is seeking a Local Regulatory Contact for their Berlin office. The ideal candidate will have a Bachelor's degree and experience in clinical trials submissions for drugs and medical devices. Responsibilities include submissions to local regulatory authorities, ensuring compliance with ICH-GCP and ISO14155, and potentially monitoring clinical studies. This position offers competitive compensation, benefits, and opportunities for professional development in a collaborative environment.

Leistungen

Competitive compensation

Benefit scheme

Development opportunities

Qualifikationen

• Experience in clinical trials submissions for medicinal products and medical devices.
• Experience in monitoring clinical studies is preferable, but not a requirement.
• Knowledge of national regulations and experience with international submissions is a plus.

Aufgaben

• Perform local clinical study application submissions in Germany, Austria, and Switzerland.
• Provide guidance on regulatory requirements for drug/device development.
• Contribute to regulatory submissions for multi-country trials if applicable.

Kenntnisse

Knowledge of ICH-GCP

Fluent in local language and English

Strong writing and IT skills

Ausbildung

Bachelor’s degree or equivalent in a relevant field

Jobbeschreibung

About us

As LINK Medical continues to grow, we currently have an open position at our office in Berlin.

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, 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 traveling 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 submit 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 honest and open communication as 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

For more information or questions about the position, please contact:

Elin Nilsson, Director Clinical Project Management

[phone]

[e-mail]

Trine Dyring, Director Clinical Operations

[phone]

[e-mail]

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