Clinical Trial Associate
Clinical Trial Associate
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Job Description
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 onsite 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 onsite 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.
- Detailoriented 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 solutiondriven 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
Employment Type
Full Time
