Job Overview
Clinical Trials Expert
This position combines the responsibilities of a Clinical Research Associate (CRA) with those of a Local Regulatory Contact. As a CRA, you will be involved in clinical trials, monitoring visits, and related tasks.
* Manage and monitor clinical trials (phases I-IV) according to protocol, ICH-GCP/ISO 14155, SOPs, and regulations.
* Conduct Source Data Review (SDR), Source Data Verification (SDV), and review Case Report Forms (CRFs).
* Experience in submitting clinical trial data for investigational medicinal products and medical devices locally and internationally is required.
You will work closely with internal and external project teams on local and international projects across various therapeutic areas.
Key Responsibilities
1. Monitor and manage clinical trials in compliance with regulations and guidelines.
2. Perform quality control checks on clinical trial data.
3. Collaborate with project teams to ensure successful project outcomes.
Skills and Qualifications:
* Strong knowledge of clinical trials regulations and guidelines.
* Excellent communication and collaboration skills.
* Ability to work independently and as part of a team.
What We Offer:
* A dynamic and supportive work environment.
* Ongoing training and development opportunities.
* The chance to work on exciting and challenging projects.