About Syneos Health
Syneos Health® is a fully integrated life sciences services organization that helps accelerate customer success across the drug development and commercialization continuum.
Key Highlights
25,000+ employees globally
Supported:
94% of novel FDA-approved drugs
95% of EMA-authorized products
Experience across large-scale clinical trials worldwide
Work Culture
Strong focus on employee development and training
Inclusive and collaborative environment
Purpose-driven mission: “Driven to Deliver”
Role Overview
Position: TMF Document Assistant (Contract)
Location: Remote (India)
Job Type: Hourly Contract
This role supports clinical trial documentation management by performing quality control (QC) of Trial Master File (TMF) documents and ensuring compliance with study-specific requirements and regulatory standards.
Key Responsibilities
1. Document Quality Control (QC)
Perform thorough QC checks on TMF documents
Ensure compliance with:
Study-specific requirements
SOPs (Standard Operating Procedures)
WIs (Work Instructions)
Identify documentation quality issues
2. Issue Management & Corrections
Address minor document corrections
Raise queries for TMF contributors when needed
Track and follow up on query resolution
3. eTMF System Management
Review, update, and add metadata in the eTMF system
Ensure documents are correctly indexed and categorized
Maintain accuracy and completeness of TMF records
4. Communication & Coordination
Follow up with TMF contributors for issue resolution
Ensure timely closure of document-related queries
Collaborate with study teams as required
5. Training & Compliance
Participate in project-specific training sessions
Ensure adherence to study and organizational processes
Support compliance with regulatory documentation standards
Qualifications
Education
Bachelor’s degree preferred (Life Sciences or related field)
Equivalent experience may be considered
Experience
Prior experience in:
Clinical documentation
TMF or eTMF systems (preferred)
Quality control or data entry (beneficial)
Skills & Competencies
Strong attention to detail
Good organizational skills
Ability to follow SOPs and structured processes
Basic understanding of clinical trial documentation (preferred)
Good communication and follow-up skills
Ability to work independently in a remote environment
Role Summary
The TMF Document Assistant is responsible for:
Ensuring accuracy and completeness of clinical trial documentation
Performing QC checks on TMF documents
Managing metadata and eTMF system updates
Supporting compliance and audit readiness of trial documentation
Work Environment
Fully remote role (India-based)
Contract (hourly basis)
Structured, process-driven clinical documentation environment
Additional Information
Responsibilities may vary based on project needs
Equivalent experience may be considered
Commitment to diversity, inclusion, and equal opportunity
Reasonable accommodations provided where required
Call to Action
Apply now or join the Talent Network for future opportunities
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