Advertisement
Looking for Senior Clinical Trial Associate jobs in India with global exposure? Hvantage Tech Solutions Pvt. Ltd. is hiring experienced professionals for a Senior Clinical Trial Associate (Sr. CTA) โ TMF/eTMF Specialist role supporting US healthcare clinical trials. This is a remote clinical research job with a strong focus on TMF management, eTMF quality control, and regulatory compliance.
If you have 5+ years of experience in clinical trial documentation, TMF/eTMF operations, and inspection readiness, this opportunity offers direct involvement in FDA-compliant clinical trials and global biotech projects.
Job Overview
- Role: Senior Clinical Trial Associate (Sr. CTA) โ TMF/eTMF Specialist
- Company: Hvantage Tech Solutions Pvt. Ltd.
- Location: Remote / Hybrid (India)
- Shift Timing: 6:30 PM โ 3:00 AM IST (US overlap)
- Experience: 5+ Years
- Employment Type: Full-Time
- Domain: Clinical Research / Pharma / Biotech / US Healthcare
Key Responsibilities
TMF/eTMF Management
- Own and manage Trial Master File (TMF/eTMF) across clinical trial phases
- Perform document upload, QC, indexing, metadata tagging, and version control
- Ensure compliance with ICH-GCP, FDA 21 CFR Part 11, ISO 14155
- Maintain inspection-ready TMF at all times
TMF Reconciliation & Quality Control
- Conduct TMF reconciliation against expected document lists
- Identify missing, duplicate, or inconsistent records
- Perform quality control (QC) checks on TMF documents
- Resolve discrepancies with clinical teams, CROs, and vendors
Documentation & Compliance
- Review clinical documents like:
- Protocols
- Informed Consent Forms (ICFs)
- Case Report Forms (CRFs)
- Clinical Study Reports (CSRs)
- Ensure adherence to ALCOA principles (data integrity)
- Support FDA/EMA audits and regulatory inspections
Metadata & Data Integrity
- Maintain accurate metadata tagging and document classification
- Ensure consistency across homegrown or non-standard systems
- Identify risks related to data inconsistencies and compliance gaps
Reporting & Analytics
- Track TMF health metrics (completeness, timeliness, quality)
- Generate reports using Advanced Excel (PivotTables, macros)
- Provide insights on compliance risks and documentation quality trends
Required Qualifications
Education
- Bachelorโs degree in Life Sciences / Pharmacy / Nursing / Health Sciences
- GCP Certification (Mandatory)
Experience
- Minimum 5+ years in clinical trial documentation or TMF/eTMF management
- Strong hands-on experience in:
- TMF upload & QC
- Inspection readiness
- Metadata management
Technical Skills
- eTMF systems (Veeva Vault preferred)
- CTMS/EDC tools: Medidata RAVE, Oracle Inform
- Advanced Excel, SharePoint
Core Competencies
- Deep understanding of ALCOA principles
- Strong attention to detail and analytical thinking
- Ability to work in decentralized and non-standard systems
- Excellent communication and stakeholder management skills
Preferred Qualifications
- Experience in US clinical trials
- Exposure to FDA inspections and EMA audits
- Background in biotech or medical device trials
- Knowledge of regulatory submissions (IDE, PMA)
Salary & Benefits
- Estimated Salary: โน8,00,000 โ โน16,00,000 per annum (based on experience)
- Work on global clinical trials with US clients
- Exposure to cutting-edge biotech and healthcare projects
- Career growth into:
- Clinical Operations Lead
- TMF Specialist Lead
- Regulatory Affairs roles
Why This Role Matters
This Senior Clinical Trial Associate job is critical because:
- TMF quality directly impacts regulatory approvals and compliance
- Errors can affect patient safety and trial outcomes
- You will ensure audit-ready documentation for global trials
How to Apply
Advertisement