IQVIA is inviting applications for the position of Sr Documents Specialist across multiple locations in India. Professionals with experience in Trial Master File (TMF) Management, Clinical Research Documentation, and Records Management can apply for this exciting hybrid opportunity.
This role is ideal for candidates looking to advance their careers in Clinical Operations, Clinical Documentation, TMF Management, and Clinical Trial Support while working with one of the world’s leading clinical research organizations.
Job Overview
- Position: Sr Documents Specialist
- Company: IQVIA
- Work Mode: Hybrid
- Experience: 2โ4 Years
- Qualification: High School Diploma or Equivalent
- Notice Period: Immediate Joiners to 60 Days
- Job Locations:
- Bangalore
- Thane
- Kochi
- Noida
- Pune
Key Responsibilities
As a Sr Documents Specialist, you will:
- Support clinical study teams with Trial Master File (TMF) activities.
- Maintain complete and inspection-ready clinical documentation.
- Manage document retrieval, indexing, scanning, and archival processes.
- Ensure compliance with SOPs, ICH-GCP guidelines, and regulatory requirements.
- Maintain records management systems and project documentation.
- Coordinate document retention, transfer, and disposal activities.
- Train internal teams on records management procedures.
- Act as the primary point of contact for document-related queries.
- Ensure TMF quality, completeness, and audit readiness.
- Support continuous process improvement initiatives.
Required Qualifications
Candidates should have:
- High School Diploma or equivalent qualification.
- 2โ4 years of experience in a Clinical Research environment.
- Strong knowledge of Trial Master File (TMF) Management.
- Experience with document management systems.
- Understanding of clinical documentation standards.
- Knowledge of records administration and archival processes.
- Familiarity with ICH-GCP, SOPs, and regulatory compliance.
- Excellent communication and organizational skills.
Preferred Skills
- Trial Master File (TMF)
- Clinical Research Documentation
- Records Management
- Document Control
- Clinical Operations
- Regulatory Compliance
- GCP Documentation
- Electronic Document Management Systems (eTMF)
- Quality Documentation
- Inspection Readiness
Why Join IQVIA?
Joining IQVIA offers professionals the opportunity to:
- Work with a global leader in Clinical Research and Healthcare.
- Gain experience supporting international clinical trials.
- Work in a hybrid environment.
- Enhance expertise in TMF and Clinical Documentation.
- Collaborate with experienced Clinical Operations teams.
- Access career development and learning opportunities.
- Build long-term growth within a leading CRO.
How to Apply
Interested candidates can send their updated resume to:
Email: angeline.preethy@iqvia.com
Please mention “Application for Sr Documents Specialist” in the subject line for faster processing.