Berlin

Handwerk, Dienstleistung und Fertigung, Wissenschaftliche Forschung & Entwicklung

Festanstellung

Perform local clinical study application submissions in Germany, Austria, and Switzerland for medicinal products and medical device studies.
Preparation and translation of submission documents including Informed Consent Forms (ICFs).
Stay up to date about local regulatory requirements for drug/device development and clinical study submissions.
Provide guidance on regulatory requirements to internal and external stakeholders.
Contribute to and coordinate regulatory and EC clinical study application submissions for multi-country trials, if applicable.
Monitor and manage clinical trials (phases I-IV) in compliance with protocol, ICH-GCP/ISO 14155, SOPs, and regulations.
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.

Bachelor’s degree or equivalent in a relevant field.
Knowledge of ICH-GCP, ISO14155, and national regulations.
Experience in clinical trials submissions for investigational medicinal products and medical devices, preferably internationally including the UK.
Experience in monitoring clinical studies and site management is preferable but not required.
Fluent in the local language and English.
Strong writing and IT skills.

Exciting and challenging position in a European CRO with a strong local presence.
Focus on collaboration, sharing of experience, and continuous development of employees.
Great working environment with dedicated and supportive colleagues.
Competitive compensation and benefit scheme.
Great development opportunities for all employees.

Adresse

10783 Berlin, Deutschland

Weitere Links

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