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

Link Medical; Berlin; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A European Clinical Research Organization is seeking a motivated Local Regulatory Contact (SSU) / Regulatory Lead in Berlin. The role involves collaboration for regulatory submissions, monitoring clinical trials, and maintaining compliance with ICH-GCP and ISO14155 standards. Ideal candidates will hold a Bachelor’s degree and possess skills in both local languages and English. This position offers competitive compensation and development opportunities in a supportive team environment.

Leistungen

Competitive compensation

Benefit scheme

Development opportunities

Qualifikationen

• Experience in clinical trial submissions for investigational medicinal products and medical devices.
• Experience in monitoring clinical studies and site management is preferable.
• Familiarity with national regulations in addition to ICH-GCP and ISO14155.

Aufgaben

• Perform local clinical study application submissions in Germany and neighboring countries.
• Monitor and manage clinical trials in compliance with relevant protocols.
• Prepare and translate submission documents, maintaining regulatory compliance.

Kenntnisse

Knowledge of ICH-GCP

Strong writing skills

IT skills

Fluent in local language

Fluent in English

Ausbildung

Bachelor's degree in a relevant field

Jobbeschreibung

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

or

• Trine Dyring, Director Clinical Operations,

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