Veni Vishnu

Highly motivated and detail-oriented Trial Master File (TMF) Specialist with a strong foundation in clinical research, regulatory compliance, and document management. Possessing a Master's in Zoology and a Postgraduate Diploma in Clinical Research, I am adept at ensuring compliance with ICH-GCP guidelines, maintaining TMF integrity, and conducting quality control processes. Currently working on TMF file review, quality check, and indexing, I am seeking an opportunity in the pharmaceutical or clinical research industry where I can leverage my expertise in TMF management and regulatory documentation to contribute to efficient clinical trials and handling different platforms -Veeva Vault, Phlex eTMF, WingSpan eTMF.

TMF Specialist - ICON Plc - Chennai, India

(2023-01)

• Comprehensive document review and quality checks to ensure compliance with regulatory guidelines.
• Regulatory Compliance & Quality Control – Strong knowledge of ICH-GCP, FDA, and EMA guidelines, ensuring document accuracy, completeness, and audit readiness.
• Clinical Documentation & Indexing – Skilled in organizing, indexing, and archiving essential clinical trial documents while maintaining Good Documentation Practices (GDP).
• Clinical Trial Coordination & Site Management – Experience in supporting study execution, investigator site coordination, and regulatory submissions.
• Risk-based Quality & Process Improvement – Ensuring adherence to SOPs and implementing process improvements to enhance trial efficiency.
• Unblinded User & Project Support – Experienced in handling unblinded roles for IPSEN projects and collaborating with cross-functional teams.
• Audit Readiness & Inspection Support – Expertise in preparing TMF for audits and inspections, ensuring all documentation meets compliance standards.
• Document Version Control & TMF Completeness – Strong ability to track, manage, and reconcile study documents to ensure TMF completeness and consistency.
• Clinical Study Start-up & Close-out Activities – Hands-on experience in managing documentation throughout the lifecycle of clinical trials, including initiation, maintenance, and close-out.
• Cross-functional Collaboration & Stakeholder Communication – Ability to liaise with internal and external teams, ensuring smooth document flow and compliance across all stakeholders.

Clinical Research Coordinator - Apollo Hospitals Research and Innovations - Chennai, India

(2021-01 - 2022-12)

• Managed clinical trial documentation, ensuring adherence to ICH-GCP and regulatory guidelines.
• Assisted in protocol execution, patient enrolment, and regulatory submissions.
• Maintained site files and coordinated with investigators, ethics committees, and sponsors.
• Conducted informed consent processes and facilitated study monitoring visits.

Clinical Research Coordinator Intern - Apollo Hospitals Research and Innovations - Chennai, India

(2021-06 - 2021-12)

Master's - Zoology

Postgraduate Diploma - Clinical Research