At TFS HealthScience, we are dedicated to advancing clinical research through innovative solutions and a commitment to quality. We provide tailored services across the clinical development lifecycle to deliver impactful results for our clients and the healthcare industry.

Role Overview:

We are looking for a Clinical Trial Associate to support TMF archiving and documentation activities on-site in Hamburg. This position involves organizing, reviewing, and maintaining physical TMF documents to ensure regulatory compliance and readiness for audits.

Contract Duration: Approximately 3 months, with the possibility of extension based on project needs and performance

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.

Ideal Candidate Profile:

• Demonstrated experience with TMF management and clinical document archiving.
• Detail-oriented and skilled in compliance with regulatory standards.
• Ability to work autonomously while maintaining clear communication with remote teams.
• Previous experience supporting audits and inspections is a plus.

A Bit More About Us

Founded over 27 years ago in Lund, Sweden, TFS HealthScience is a global Contract Research Organization. With more than 800 professionals across 40 countries, we offer flexible, solution-driven clinical research services in key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide us in creating a unified, innovative, and collaborative culture, driving us towards a healthier future