Syneos Health
10,000+ employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
TMF Specialist – Safety Processing, Min 2 Years Experience in Central File Management
🔥 3 hours ago
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Syneos Health
10,000+ employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
📋 Description
• 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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