Senior TMF Specialist
Job Title: Senior TMF Specialist
Location: Chennai, India
Work Model: Office With Flex
Employment Type: Full-Time
Job Requisition ID: JR146301
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization committed to accelerating the development of innovative medicines and therapies that improve patient outcomes worldwide.
Built on the values of Integrity, Collaboration, Agility, and Inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality clinical research solutions while maintaining regulatory excellence.
Position Overview
ICON is seeking an experienced Senior TMF Specialist to support Trial Master File (TMF) management activities across clinical studies. The role is responsible for ensuring that electronic Trial Master Files (eTMFs) remain complete, accurate, compliant, and inspection-ready throughout the clinical trial lifecycle.
The ideal candidate will possess extensive experience in periodic file reviews, document reconciliation, co-dependency checks, cross-check validation, and identification of missing TMF documentation using systems such as Veeva Vault.
This position plays a critical role in maintaining regulatory compliance and supporting successful audits, inspections, and clinical trial execution.
Key Responsibilities
eTMF Review & Completeness Assessment
Perform comprehensive:
eTMF Completeness Reviews
Periodic Reviews
Milestone Reviews
Conduct detailed assessments of study documentation within electronic Trial Master Files.
Ensure all required documents are present, complete, and appropriately filed.
Cross-Checks & Co-Dependency Reviews
Perform advanced:
Cross-checks
Co-dependency checks
Document reconciliation activities
Identify missing, incomplete, duplicate, or incorrectly filed documents.
Validate document relationships and dependencies across TMF sections.
Ensure consistency between related study records and documentation.
Inspection Readiness
Maintain allocated studies in an inspection-ready state at all times.
Support readiness for:
Sponsor audits
Regulatory inspections
Internal quality reviews
Identify compliance risks and implement corrective actions as required.
Expected Document List (EDL) Management
Review and update Expected Document Lists (EDLs) throughout the study lifecycle.
Ensure document expectations align with study milestones and regulatory requirements.
Monitor document collection progress and identify outstanding records.
Document Quality & Compliance Review
Conduct ALCOEA reviews to ensure documentation meets quality standards:
Attributable
Legible
Contemporaneous
Original
Enduring
Accurate
Perform metadata quality checks for accuracy and consistency.
Ensure compliance with:
ICH-GCP Guidelines
TMF Reference Model
Regulatory requirements
Company SOPs
Stakeholder Collaboration
Work closely with:
TMF Leads
Clinical Study Teams
Clinical Operations
Regulatory Teams
Quality Assurance Teams
Gather review requirements and provide TMF review findings.
Track and follow up on action items until closure.
Escalate critical TMF issues when necessary.
Training & Knowledge Sharing
Conduct training sessions for internal teams on:
TMF best practices
Compliance requirements
Document management procedures
Provide guidance and support to team members regarding TMF-related queries.
Promote continuous improvement and knowledge sharing across teams.
Service Delivery & Operational Excellence
Adhere to agreed Service Level Agreements (SLAs).
Ensure all deliverables are completed within defined timelines.
Contribute to process improvements that enhance TMF quality and efficiency.
Required Qualifications
Education
Required
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Clinical Research
Healthcare
Related Scientific Discipline
Preferred
Master's Degree or other advanced qualification in a relevant field.
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