Hire Omkar

Omkar Mahajani

TMF Lead

Results-driven Clinical Research and TMF Management professional with 10+ years of experience in managing the complete Trial Master File (TMF) lifecycle across global pharmaceutical and CRO environments. Proven expertise in TMF inspection readiness, quality oversight, and regulatory compliance (ICH-GCP, CFR, EMA, MHRA). Adept at stakeholder coordination, documentation excellence, and audit preparation, ensuring TMF accuracy and integrity from study startup to closeout. Recognized for process improvements, cross-functional training, and maintaining audit-ready environments across multiple therapeutic domains.

FORMERLY AT

Parexel International India Pvt. Ltd

LOCATION

Banglore,India

AVAILABILITY

Full Time

Skills

CTMS

eTMF

Excel Audit Tracker

MS Excel Dashboards

MS Word Templates

PhlexTMF

Regulatory Filing Portals

TMF Metrics Reporting Tools

Veeva Vault eTMF

Wingspan

Work Experience

TMF Lead

Parexel International India Pvt. Ltd. |

Jun 2022 – Present

Oversee TMF operations for global clinical studies through setup, maintenance, and archival phases.
Conduct TMF quality reviews, milestone tracking, and audit/inspection readiness checks.
Develop and implement TMF management plans (CFMP) aligned with sponsor SOPs.
Lead cross-functional TMF review meetings, ensuring timely deliverables and risk mitigation.
Provide TMF trainings to teams and ensure consistent documentation practices.
Collaborate with sponsors to enhance document control systems and ensure compliance with ICH-GCP and global regulations.

TECHNOLOGIES

Veeva Vault eTMF, Wingspan, PhlexTMF, CTMS, MS Excel Dashboards, TMF Metrics Reporting Tools

TMF Specialist

Tata Consultancy Services Pvt. Ltd

Mar 2017 – Jun 2022

Supported global R&D clinical trial documentation for multiple therapeutic studies.
Conducted TMF completeness and quality checks, milestone reviews, and document reconciliation.
Managed audit readiness, version control, and document archiving within project timelines.
Generated and analyzed TMF metrics for performance tracking and risk analysis.
Contributed to SOP development and process standardization initiatives for TMF operations.
Coordinated with study teams for issue resolution and data quality improvement.

TECHNOLOGIES

Wingspan, Veeva Vault, Documentum, CTMS, MS Excel (Metrics Dashboard), SharePoint

Clinical Research Associate

Alkem Laboratories Ltd.

Aug 2015 – Mar 2017

Managed Phase I and bioequivalence (BE) clinical studies ensuring compliance with ICH-GCP.
Oversaw volunteer recruitment, informed consent documentation, and IP accountability.
Maintained TMF documentation, monitored CRFs, and ensured regulatory adherence.
Supported site audits and quality control activities to ensure protocol compliance.
Liaised with clinical investigators and QA for issue resolution and trial documentation accuracy.