Senior Clinical Trial Associate (Sr. CTA) - TMF/eTMF Specialist (US Healthcare Trials)

Job Title: Senior Clinical Trial Associate (Sr. CTA) – TMF/eTMF Specialist (US Healthcare Trials)

Company: Hvantage Tech Solutions Pvt. Ltd.

Location: Remote / Hybrid (India)

Working Hours: 6:30 PM – 3:00 AM IST (US Time Zone Overlap)

Employment Type: Full-Time

Experience Required: 5+ Years

Domain: Clinical Research / US Healthcare / Biotech / Pharma

About Hvantage Tech Solutions Pvt. Ltd.

Hvantage Tech Solutions Pvt. Ltd. is a global provider of technology-driven healthcare and life sciences solutions, supporting clinical trials, healthcare data platforms, and regulatory compliance initiatives for clients across the US and global markets. We specialize in enabling high-quality, compliant, and scalable clinical operations through deep domain expertise and advanced technology integration.

Position Overview

We are seeking a highly experienced Senior Clinical Trial Associate (Sr. CTA) with a strong focus on TMF/eTMF management, documentation quality, and regulatory compliance .

This role is documentation-intensive and quality-critical , requiring:

• Deep hands-on experience in TMF/eTMF operations
• Strong understanding of ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate)
• Expertise in upload, QC (Quality Control), metadata handling, and inspection readiness
• Ability to work effectively in non-standard or “homegrown” document management systems

The ideal candidate will have prior experience in small to mid-size biotech environments , where:

• Documentation is often decentralized
• Systems may not be standardized (e.g., non-Veeva environments)
• Greater ownership and critical thinking is required

Key Responsibilities

1. TMF / eTMF Management & Ownership (CORE RESPONSIBILITY)

• Own and manage the Trial Master File (TMF/eTMF) across all clinical trial phases.
• Perform end-to-end TMF activities , including:
• Document upload
• Quality Control (QC)
• Indexing
• Metadata tagging
• Version control
• Ensure compliance with:
• ICH-GCP
• FDA 21 CFR Part 11
• ISO 14155
• Apply ALCOA principles rigorously to all documentation activities.
• Maintain continuous inspection readiness :
• Identify missing documents
• Resolve discrepancies proactively
• Maintain audit trails

2. TMF Reconciliation-

- Conducted periodic reconciliation of the Trial Master File (TMF) against expected document lists to ensure completeness and regulatory compliance.

- Cross-checked TMF contents with study trackers, vendor deliverables, and site documentation to identify missing, duplicate, or inconsistent records.

- Collaborated with cross-functional teams (Clinical Operations, CROs, and vendors) to resolve discrepancies and ensure timely document filing.

- Maintained reconciliation logs and generated reports highlighting gaps, risks, and corrective actions.

- Ensured alignment of TMF documents with regulatory requirements such as ICH-GCP and internal SOPs.

- Supported inspection readiness by ensuring TMF completeness and audit traceability.

3. TMF Quality Control (QC)

- Performed quality control (QC) reviews of TMF documents to ensure accuracy, completeness, and compliance with applicable SOPs and regulatory standards.

- Verified document metadata, indexing, version control, and proper filing within the eTMF system.

- Identified and flagged quality issues such as incorrect document types, missing signatures, or incomplete records.

- Ensured consistency in naming conventions, formatting, and classification of TMF artifacts.

- Coordinated with document owners to resolve QC findings and ensure timely closure.

- Contributed to continuous improvement initiatives by identifying recurring QC issues and recommending process enhancements.

4. Document Quality Review & Critical Thinking

• Conduct in-depth QC reviews of TMF documents, ensuring:
• Accuracy
• Completeness
• Compliance with study protocols
• Evaluate documentation for:
• Logical consistency
• Regulatory alignment
• Data integrity risks
• Apply critical thinking to identify:
• Gaps in documentation
• Inconsistent metadata
• Misaligned records across systems
• Collaborate with cross-functional teams to resolve quality issues proactively

5. Working with Homegrown / Non-Standard Systems

• Effectively manage documentation within custom-built or decentralized systems
• Adapt to environments where:
• Documentation is distributed across multiple repositories
• Standardized tools like Veeva Vault may not be used
• Ensure consistency, traceability, and compliance across systems
• Develop internal processes and best practices to improve documentation quality

6. Clinical Documentation Management

• Prepare, review, and maintain key trial documents:
• Protocols
• Informed Consent Forms (ICFs)
• Case Report Forms (CRFs)
• Clinical Study Reports (CSRs)
• Manage document lifecycle:
• Creation → Review → Approval → Archival
• Ensure proper document classification and indexing

7. Regulatory Compliance & Audit Readiness

• Ensure adherence to:
• GCP, FDA, EMA, and ISO standards
• Support:
• Regulatory submissions
• Inspection readiness activities
• Prepare for and assist in:
• Internal audits
• External inspections (FDA/EMA)
• Implement and track CAPA (Corrective and Preventive Actions)

8. Site Coordination & Communication

• Coordinate with:
• Clinical sites
• Investigators
• Sponsors
• Support:
• Site Initiation Visits (SIV)
• Monitoring visits
• Close-out activities
• Act as a primary documentation liaison across stakeholders

9. Metadata Management & Data Integrity

• Ensure accurate and consistent:
• Metadata tagging
• Document categorization
• Maintain strong data governance practices
• Identify and resolve:
• Metadata inconsistencies
• Document duplication issues

10. Reporting & Analytics

• Track TMF health metrics:
• Completeness
• Timeliness
• Quality scores
• Generate reports using:
• Advanced Excel (PivotTables, macros)
• Internal dashboards
• Provide insights to leadership on:
• Documentation quality trends
• Compliance risks

11. Risk Identification & Problem-Solving

• Identify risks related to:
• Documentation gaps
• Regulatory non-compliance
• Data inconsistencies
• Perform root cause analysis and implement solutions
• Proactively mitigate risks before audits

Required Qualifications

Education

• Bachelor’s degree in:
• Life Sciences / Health Sciences / Nursing / Pharmacology or related field
• GCP Certification (Mandatory)

Experience

• Minimum 5+ years of experience in:
• Clinical trial documentation
• TMF/eTMF management
• Strong hands-on experience with:
• TMF upload & QC processes
• Inspection readiness
• Metadata management
• Experience working in:
• Small to mid-size biotech organizations (highly preferred)

Technical Skills

• TMF/eTMF systems (Veeva Vault preferred, but NOT mandatory)
• Experience working in non-standard/homegrown systems
• CTMS / EDC tools:
• Medidata RAVE
• Oracle Inform
• Advanced Excel
• SharePoint / document collaboration tools

Core Competencies (CRITICAL)

'14; Deep understanding of ALCOA principles

'14; Strong attention to detail

'14; Exceptional documentation quality mindset

'14; Strong analytical & critical thinking skills

'14; Ability to work independently in decentralized environments

'14; Strong communication & stakeholder management

Preferred Qualifications

• Experience in US clinical trials
• Exposure to:
• FDA inspections
• EMA audits
• Experience with:
• Medical device trials
• Biotech / early-stage companies
• Knowledge of:
• Regulatory submission processes (IDE, PMA)

Work Environment & Expectations

• Work in US time zone overlap (6:30 PM – 3:00 AM IST)
• High accountability for documentation quality and compliance
• Fast-paced, cross-functional collaboration
• Ability to work independently with minimal supervision

Impact of the Role

This role is mission-critical as:

• TMF errors can directly impact:
• Trial approvals
• Regulatory compliance
• Patient safety
• You will be responsible for ensuring audit-ready documentation at all times

Why Join Hvantage -

• Work on global clinical trials with US clients
• Exposure to cutting-edge healthcare & biotech environments
• Opportunity to work in high-impact, compliance-critical roles
• Growth into:
• Clinical Operations Lead
• TMF Specialist Lead
• Regulatory Affairs roles