Clinical Trial Documentation Specialist
hace 3 días
Company Overview: TFS HealthScience is a global Contract Research Organization founded over 27 years ago in Lund, Sweden. We offer flexible, solution-driven clinical research services in key therapeutic areas.
We have more than 800 professionals across 40 countries, providing innovative solutions and a commitment to quality. Our core values guide us in creating a unified, collaborative culture driving us towards a healthier future.
Job DescriptionJob Title: Clinical Trial Associate
The successful candidate will support TMF archiving and documentation activities on-site in Hamburg. This role involves organizing, reviewing, and maintaining physical TMF documents to ensure regulatory compliance and readiness for audits.
Key Responsibilities:
- TMF Compilation and Maintenance: Organize and file physical study documents for accessibility and structure.
- Ensure completeness and accuracy of TMF records to reflect current study status.
- Document Management: Archive, review, and organize essential trial documentation to meet regulatory requirements.
- Conduct TMF audits, identify documentation gaps, and collaborate with team members to address deficiencies.
- Compliance Adherence: Ensure all TMF records align with regulatory standards and internal quality controls.
- Provide on-site support for audits and inspections as required.
- Collaboration and Reporting: Independently gather required documents from clinical team members, CROs, and vendors.
- Maintain regular reporting on TMF compliance, completion, and any outstanding needs.
We are looking for a detail-oriented individual with demonstrated experience in TMF management and clinical document archiving. The ideal candidate should be skilled in compliance with regulatory standards and able to work autonomously while maintaining clear communication with remote teams.
BenefitsAs a Clinical Trial Associate at TFS HealthScience, you can expect a competitive salary of €45,000 - €55,000 per year, depending on your qualifications and experience. Additionally, we offer a range of benefits, including professional development opportunities and a dynamic work environment.
Our estimated annual salary includes a basic salary of €43,500, plus a performance-based bonus of up to €8,000. This total compensation package reflects our commitment to recognizing and rewarding outstanding performance.
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