Senior Document Management Associate (SDMA)
Location: India
Company: Novotech (Global Clinical Contract Research Organization – CRO)
Job Overview
The Senior Document Management Associate (SDMA) supports Trial Master File (TMF) activities for clinical research projects. The role ensures proper management of both paper and electronic TMFs in compliance with ICH-GCP guidelines, regulatory requirements, and company/client SOPs. The SDMA also performs quality control (QC) reviews and mentors junior team members.
Key Responsibilities
A. TMF Document Management (Uploader Role)
1. Document Handling & Filing
Receive, track, and maintain study documentation for assigned projects
Manage both electronic TMF (eTMF) and paper TMF systems
Scan, upload, and file documents as per SOPs (Novotech/client requirements)
Ensure proper organization using systems like SharePoint and other study platforms
2. Document Quality & Compliance
Review documents for completeness and quality before filing
Ensure adherence to ICH-GCP guidelines and essential document requirements
Collaborate with project teams to resolve document gaps or issues
3. Reporting & Tracking
Provide regular reports on document quality and collection status
Prepare monthly TMF accuracy reports for project teams
Maintain departmental tracking reports and documentation logs
4. TMF Maintenance & Inspection Readiness
Ensure TMF is always “inspection ready”
Maintain timely and contemporaneous filing of documents
Support preparation for audits, regulatory inspections, and study closeouts
Perform interim eTMF exports/uploads for sponsors or third parties
5. Quality & Issue Management
Resolve internal QC findings and audit issues
Support corrective actions for document-related discrepancies
Create checklists and daily QC schedules for monitoring
6. Administrative & Support Tasks
Maintain archived study files and paper documentation organization
Participate in departmental meetings and process improvement activities
Support development of SOPs and clinical processes
Ensure professional communication with external stakeholders
B. QC Reviewer Role
1. QC Review Execution
Work with Central Filing Team Lead for project assignments
Perform QC reviews quarterly or as per study requirements
Ensure compliance with TMF standards and SOPs
2. Issue Tracking & Resolution
Develop QC checklists for review processes
Share findings with project teams for resolution
Track and ensure closure of QC queries within timelines
C. Leadership & Mentoring
Train and mentor new Document Management Associates (DMAs)
Support team development and knowledge sharing
Contribute to improving TMF processes and team efficiency
Qualifications
Minimum Requirements
2+ years of experience in a Clinical Research Organization (CRO) or similar role
Hands-on experience in Trial Master File (TMF) management (paper and/or eTMF)
Knowledge of ICH-GCP guidelines and regulatory documentation standards
Preferred Experience
Background in pharmaceutical, CRO, or healthcare industry
Experience with clinical 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. Since 1997, the company has grown into a leading clinical research partner supporting biotech and pharmaceutical companies in bringing therapies to market.
Work Culture & Benefits
Award-winning employer (Great Place to Work, Employer of Choice)
Inclusive and gender-equal workplace
Flexible work arrangements and leave policies
Parental leave for both parents
Wellness and professional development programs
Mentorship and career growth opportunities
Team Environment
Collaborative, global, and client-focused culture
Strong emphasis on innovation and scientific expertise
Empowered teams with cross-functional collaboration
Supportive leadership and open communication culture
Focus on strategic thinking and proactive decision-making
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