Document Management Associate (DMA)
Location: India
Company: Novotech (Global Clinical Contract Research Organization – CRO)
Job Overview
The Document Management Associate (DMA) supports Trial Master File (TMF) activities for clinical research projects. The role involves managing both electronic and paper TMFs in compliance with ICH-GCP guidelines, regulatory requirements, and Novotech/client SOPs. The DMA ensures accurate documentation, timely filing, and inspection readiness throughout the study lifecycle.
Key Responsibilities
A. TMF Document Management
1. Document Receipt & Filing
Receive all study documentation for assigned projects
Set up, track, and maintain electronic TMF (eTMF) and paper TMF systems
Scan, upload, and file documents according to SOPs and project requirements
Ensure proper documentation handling using systems such as SharePoint and other TMF platforms
2. Document Quality Control
Review incoming documents for completeness and quality
Ensure compliance with Novotech essential document requirements
Collaborate with study teams to resolve documentation issues
3. System & Process Compliance
Follow ICH-GCP guidelines and company/client SOPs
Ensure adherence to TMF processes, KPIs, and quality standards
Maintain accurate filing across all study systems throughout the study lifecycle
B. Reporting & Tracking
Provide updates on document quality and collection status
Generate reports on TMF accuracy and documentation progress
Conduct monthly file reviews and maintain departmental reports
Track study documentation to ensure timely submission and filing
C. Inspection & Audit Readiness
Maintain TMF in an “inspection ready” state at all times
Prepare TMF for audits, regulatory inspections, and study closeouts
Support TMF exports and uploads for sponsors or third parties
Assist during audits and resolve findings from QC or regulatory reviews
Ensure contemporaneous (real-time) filing of documents
D. Quality Issue Management
Address internal QC findings and audit observations
Resolve documentation discrepancies within timelines
Create QC checklists and daily quality control schedules
Support continuous improvement in document management processes
E. Administrative & Support Activities
Maintain archived study documentation and paper file organization
Run and maintain departmental reports
Perform special TMF-related projects (e.g., archive maintenance, file location organization)
Participate in departmental meetings and contribute to SOP/process improvements
Represent Novotech professionally in all external communications
Minimum Qualifications & Experience
Minimum 12 months experience in a Clinical Research Organization (CRO) or equivalent role
Hands-on experience in Trial Master File (TMF) management (paper and/or electronic TMF)
Familiarity with ICH-GCP guidelines and clinical documentation standards
Preferred Qualifications
Experience in pharmaceutical, CRO, or healthcare industry
Exposure to clinical trial documentation systems (eTMF platforms, SharePoint, etc.)
About Novotech
Novotech is a global full-service clinical Contract Research Organization (CRO) operating across Asia-Pacific, the United States, and Europe. The company supports biotech and pharmaceutical organizations in accelerating clinical development and bringing new therapies to market.
Work Culture & Benefits
Recognized Employer of Choice and Great Place to Work
Inclusive and gender-equal workplace environment
Flexible working arrangements and leave policies
Paid parental leave for both parents
Wellness and employee support programs
Continuous learning and professional development opportunities
Team Environment
Collaborative global clinical research teams
Strong focus on regulatory excellence and quality compliance
Culture of partnership, inclusion, and knowledge sharing
Empowerment to make proactive, data-driven decisions
Support from leadership and cross-functional stakeholders
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