Role Description
- Coordinate the preparation and submission of clinical trial applications to national regulatory authorities and ethics committees.
- Collect and review essential site documents, such as investigator CVs, medical licenses, and financial disclosure forms, ensuring they are "audit-ready."
- Develop and customize country-specific informed consent forms (ICFs) and other patient-facing materials.
- 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.
Qualifications
- Min 1 years of experience in clinical trial submissions for Sweden
- Min 1 years of experience in clinical trial agreements for Sweden
- Fluent Swedish and English
if you can not apply here please email your cv to [email protected]