TMF Specialist – Safety Processing, Min 2 Years Experience in Central File Management
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Job Description
TMF Specialist managing safety processing for clinical trials at Syneos Health. Requires 2+ years in central file management and relevant pharmaceutical experience.
Responsibilities:
- Process TMF documents received per good documentation practices, TMF readiness criteria and other reference documents
- Demonstrate understanding of document types, properties and indexing requirements
- Ensure overall TMF quality in terms of document completeness, indexing and scanning accuracy
- Process documents in the TMF system(s) within specified timelines, based on document criticality/priority
- Communicate document inquiries with responsible users as needed
- Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues
- Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations when needed
- Contribute to process improvement initiatives and projects that may arise
Requirements:
- Minimum of a Bachelor’s degree or equivalent
- Minimum of 2 years of relevant experience in central file management for clinical trials
- Experience in the pharmaceutical industry or at a CRO in a similar role
- Experience working in a global environment, as the role involves communicating with the Asia-Pacific team
- Solid knowledge of ICH/GCP documents requirements
- Effective verbal and written communication skills with internal and external teams
- Strong technical proficiency and the ability to learn and use various systems
Benefits:
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition
- total rewards program
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