Fleming Research Engineering
Start up Specialist / CRA
Job Description
Responsibilities
- Coordinate the preparation and submission of clinical trial applications to national regulatory
- Maintain accurate tracking of submission timelines and approval statuses within the clinical trial management system (CTMS).
- Serve as the primary point of contact for investigative sites during the initiation phase, providing guidance on regulatory requirements.
- Ensure the electronic trial master file (eTMF) is complete and compliant with ICH-GCP standards prior to site activation.
- Site monitoring / Site initiation
Qualifications
- Min 2 years of experience in clinical trial submissions
- Fluent German and English