Job Overview
We are seeking a highly motivated Regulatory Contact Study Start-Up / Regulatory Lead to join our team. As a key member of our project team, you will be responsible for managing clinical trials in compliance with regulatory requirements.
Key Responsibilities:
* Manage clinical trials (phases I-IV) in accordance with protocols, regulations, and SOPs
* Perform Source Data Review (SDR), Source Data Verification (SDV), and review Case Report Forms (CRFs)
* Collaborate with internal and external teams to ensure successful trial execution
* Ensure compliance with ICH-GCP/ISO 14155 and other relevant regulations
Requirements:
* Bachelor's degree or equivalent in a relevant field
* Experience in clinical trials submissions for investigational medicinal products and medical devices
* Fluency in English and local language
What We Offer:
* A competitive compensation package
* A great working environment with dedicated colleagues
* Ongoing development opportunities in an international environment