
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
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.
🕒 July 14
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10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
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.
• Process and review safety documents exclusively • Process TMF documents according to good documentation practices, TMF readiness criteria, and reference documents • Demonstrate understanding of document types, properties, and indexing requirements • Ensure TMF quality through document completeness, indexing, and scanning accuracy • Process documents in TMF systems within specified timelines based on criticality and priority • Communicate document inquiries with responsible users • Liaise with Document Owners, TMF Study Owners, and other end users to resolve discrepancies and issues • Communicate and escalate issues to the TMF Document Specialist Lead and TMF Operations • Contribute to process improvement initiatives and projects • Serve as a Subject Matter Expert for TMF processes, systems, and related tools where applicable
• Minimum of a Bachelor’s degree or equivalent • Advanced English proficiency for communication with global stakeholders • 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 • Solid knowledge of ICH/GCP document requirements • Effective verbal and written communication skills with internal and external teams • Strong technical proficiency and ability to learn and use various systems
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture supporting authenticity and inclusion • Diversity, equity, and belonging-focused workplace culture • Reasonable accommodations for applicants and employees with disabilities
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