IQVIA, a global leader in clinical research services, healthcare intelligence, and life sciences consulting, is currently hiring a TMF Specialist to support Trial Master File (TMF) and records management activities for clinical research projects.
This opportunity is ideal for professionals with experience in clinical trial documentation, eTMF management, regulatory compliance, and records management within clinical research environments. The role involves working closely with project teams, ensuring that clinical trial documentation is maintained according to ICH-GCP guidelines and regulatory requirements.
The TMF Specialist will act as a key liaison between Records Management teams and clinical research departments, ensuring that Trial Master Files remain accurate, compliant, and audit-ready throughout the lifecycle of clinical trials.
Professionals with knowledge of clinical research documentation, GCP guidelines, trial master file structure, and regulatory compliance in clinical trials are strongly encouraged to apply.
Key Responsibilities – TMF Specialist (Clinical Trials)
The selected candidate will support clinical trial records management and Trial Master File operations, including:
- Ensuring Trial Master File (TMF) documentation compliance with SOPs and regulatory guidelines
- Monitoring filing accuracy and document completeness within clinical trial records systems
- Coordinating records retrieval requests from project teams and stakeholders
- Preparing closed clinical studies for archival transfer to clients or storage facilities
- Maintaining records center security and compliance with records management policies
- Supporting clinical teams in accessing trial documents and regulatory records
- Monitoring document filing in accordance with IQVIA or sponsor file plans
- Coordinating transfer, recall, and disposition of records to external storage facilities
- Managing records lifecycle including storage, retrieval, and destruction of obsolete files
- Training team members on records management policies and Trial Master File procedures
- Serving as primary contact for internal stakeholders and clients regarding TMF activities
- Supporting strategic planning and operational improvements in records management processes
Required Qualifications
Candidates applying for the IQVIA TMF Specialist role should meet the following criteria:
Education
- High School Diploma or equivalent (minimum requirement)
- Additional education in life sciences, clinical research, or records management preferred
Experience
- Minimum 3 years of experience in records management or clinical documentation management
Required Knowledge
- Strong understanding of ICH Guidelines
- Knowledge of Good Clinical Practice (GCP)
- Familiarity with clinical trial documentation and Trial Master File (TMF) structure
- Knowledge of regulatory requirements governing clinical research
Key Skills
- Records management and documentation control
- Attention to detail and regulatory compliance
- Strong communication and coordination skills
- Ability to manage multiple clinical research projects simultaneously
- Problem-solving and analytical thinking
- Leadership and training abilities
Benefits of Working at IQVIA
Joining IQVIA’s clinical research team offers several career advantages:
- Opportunity to work with a global leader in clinical research and healthcare analytics
- Exposure to international clinical trials and regulatory frameworks
- Collaborative environment with global project teams
- Strong career growth in clinical operations, TMF management, and regulatory documentation
- Experience supporting high-impact clinical research programs
How to Apply
