Line Head – TMF Central Upload and Quality Review
Company: Bristol Myers Squibb (BMS)
Location: Hyderabad, Telangana, India
Job Type: Full-time (Hybrid / Site-based depending on role structure)
Job ID: R1601595
1. Role Overview
This is a people management and quality leadership role responsible for overseeing the electronic Trial Master File (eTMF) upload and quality review operations.
The role ensures:
Inspection-ready TMF documentation
Regulatory compliance (ICH-GCP, ALCOA+ principles)
High-quality document management across clinical trials
Efficient team execution and resource allocation
2. Core Responsibilities
A. Team Leadership & Resource Management
Lead a team of eTMF Specialists
Allocate staff across clinical trial workloads based on priority
Manage:
Hiring
Training
Performance evaluations
Coaching and development
Ensure team compliance with SOPs and regulatory standards
B. TMF Quality & Compliance Oversight
Ensure accurate upload and classification of clinical trial documents
Oversee quality review of eTMF content
Maintain inspection readiness at all times
Ensure compliance with:
ICH-GCP guidelines
ALCOA+ data integrity principles
Health authority regulations
C. Process & Document Management
Ensure proper application of:
Metadata tagging
Document attributes
Workflow processes in eTMF systems (e.g., Veeva Vault eTMF)
Ensure proper document classification, retrieval, and traceability
D. Performance Monitoring & Metrics
Monitor TMF quality metrics, KPIs, and dashboards
Identify compliance gaps and risks
Implement corrective actions and remediation plans
Ensure timely resolution of quality issues
E. Training & Capability Building
Ensure team is trained on:
eTMF systems
Clinical documentation standards
Regulatory requirements
Deliver coaching and targeted training programs
Support continuous learning across the team
F. Cross-Functional Collaboration
Work with clinical operations and quality teams
Support end-to-end clinical trial documentation processes
Improve TMF operational efficiency through collaboration
G. Continuous Improvement
Lead initiatives to improve:
TMF processes
Document workflows
Quality systems
Drive operational efficiency and compliance improvements
3. Required Qualifications
Experience
5–7 years experience in:
Health sciences OR regulated clinical environment
Experience in:
eTMF operations
Clinical document management systems
Leadership
Prior supervisory/line management experience required
Experience in:
Training teams
Coaching staff
Managing performance
4. Technical Skills
Strong knowledge of:
TMF principles
eTMF systems (preferably Veeva Vault eTMF)
Experience with:
Clinical trial documentation workflows
Quality review processes
Proficiency in:
Microsoft Excel
PowerPoint
SharePoint
Power BI (reporting & dashboards)
5. Regulatory & Domain Knowledge
Strong understanding of:
ICH-GCP guidelines
Clinical trial regulatory requirements
TMF compliance standards
Knowledge of:
Health authority inspection expectations
Clinical documentation lifecycle
6. Key Competencies
Leadership
Team management
Coaching & mentoring
Performance management
Quality & Compliance
Inspection readiness mindset
Risk identification and mitigation
Audit support
Technical & Analytical
Document systems expertise
Reporting & dashboard interpretation
Data accuracy & classification
Soft Skills
Strong communication skills
Organizational ability
Stakeholder management
Attention to detail
7. Role Impact
This role ensures:
Clinical trial documentation is complete, accurate, and inspection-ready
Regulatory compliance across global studies
Efficient TMF operations supporting drug development programs
Strong quality governance across clinical documentation systems
8. Role Level Insight
This is a mid-to-senior leadership role, positioned between:
Operational team leads (eTMF specialists)
and
Director-level clinical quality leadership
It is primarily:
People management + quality governance + compliance leadership
9. Simple Summary
You are basically:
Leading a TMF operations team that ensures all clinical trial documents are correctly uploaded, reviewed, and audit-ready for global regulatory inspections.
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