- Entry level
- No Education
- Salary to negotiate
- BELGIUM BE
Clinical Specialist: Trial Master File Expert (m/f) - Brussels / Belgium
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
The Trial Master File (TMF) Expert supports the clinical study team proactively with full responsibility in all aspects of the maintenance and TMF process set up of the study TMF by supporting the Project Manager and document owners and addresses ad-hoc issues being the Trial Master File (TMF) study owner.
Specific tasks would include:
- Ensure high quality and up-to-date TMF management being embedded in different clinical study teams
- Own and maintain the study TMF management plan and ensures adherence by the study team members
- Support the Project Manager in planning and executing TMF management-related activities of the clinical trial team in order to ensure that the TMF is in good shape and updated on a timely manner
- Responsible to track eTMF-periodic reviews for studies and provide regular updates to the SDL/Head TMF Operations
- Primary point of contact for study team members for any TMF-related question
- In charge of the set-up of the TMF for each new study (on-boarding of study contributors, TMF plan, performing preparation of the documents in the system)
- In charge, during the maintenance of the TMF that the contributors are providing their documentation on an in-stream basis (by running KPI, by running reports, by running QC checks if needed).
- Proactively take the appropriate relevant actions to address gaps, issues and risks and make suggestions for improvement
- Provide training to newcomers and refresher training to existing users
- Collect study wet-ink paper documents, prepares the wet-ink documents for archiving, arrange shipments of those to the clinical archiving team for long term retention
- Lead inspection/audit preparation related activities with regards to study-related documentation
- Scientific degree or mix between administrative degree and relevant work experience
- Relevant working experience in a pharmaceutical / scientific environment is a must as well as knowledge of clinical trials (including ICH-GCP) and exposure to document management
- Expertise in project planning & project management is an asset
- Ability to set and manage priorities, performance targets, multiple tasks and project initiatives in a global environment
- Provide negotiation and presentation skills and be customer oriented
- Ability to work independently, within a team in a matrix organization connecting with a broad range of cultures
- Organized, methodical and attention to detail and conflict resolution
- Engish language skills are a must
If you're passionate about bringing clinical trials to life, we encourage you to apply today! Please apply online stating your earliest start date/notice period and your desired salary. If you have any questions regarding your application please contact Antonia.Schultze@synteract.com .
- scientists and researchers