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

Overview

Local Regulatory Contact SSU/Regulatory Lead (Clinical Studies)/ (Sr) CRA position in Germany. The role involves collaboration with internal and external project teams, working on local and international projects across therapeutic areas. The position can be combined with a CRA role and may include travel related to monitoring visits.

Responsibilities

• Perform local clinical study application submissions in Germany, primarily, with activity also in Austria and Switzerland (medicinal products and medical devices; interventional and non-interventional studies).
• Prepare and translate submission documents (including ICFs).
• Stay up to date with local regulatory requirements for drug/device development and clinical study submissions.
• Provide guidance on regulatory requirements (internal and external).
• Optional (dependent on experience): Contribute to and coordinate regulatory and EC clinical study application submissions for multi-country trials (including Clinical Trials with IMPs via CTIS).
• If applicable, 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.

Desired 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 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.

Personal characteristics

• Service-minded with strong communication and presentation skills.
• Well-organized, able to work both independently and within teams.
• Independent, flexible, accurate, and solution oriented.
• Demonstrates initiative and adapts well to changing situations.
• Focuses on customer needs, works methodically, and achieves project goals consistently.
• Open to new ideas, adaptable to different people and cultures.

LINK Medical offers

We offer an exciting and challenging position in a European CRO with a strong local presence. The company emphasizes collaboration, experience sharing, and ongoing development of employees in an international environment, with values centered on honest and open communication. You will engage in meaningful tasks requiring efficient collaboration between industry, clinical and scientific teams, and the authorities. The role provides a great working environment with dedicated colleagues, and offers competitive compensation, a benefit scheme, and development opportunities for all employees.