Clinical Trial Associate

vor 1 Woche

Hamburg, Deutschland TFS HealthScience Vollzeit

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.
- 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

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