Clinical Trial Associate
hace 4 días
At TFS HealthScience, we strive to advance clinical research through innovative solutions and a commitment to quality.
Role Overview:
We are seeking 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.
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.
We offer a competitive salary of €40,000 - €50,000 per year, depending on qualifications and experience, plus additional benefits and opportunities for professional growth.
About Us:
TFS HealthScience is a global Contract Research Organization founded over 27 years ago in Lund, Sweden. We have over 800 professionals across 40 countries, offering flexible, solution-driven clinical research services in key therapeutic areas, including Dermatology, Neuroscience, Oncology, and Ophthalmology.
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