Jul 2018 – Nov 2020 · 2 yrs 4 mos

• Led TMF Quality oversight for multiple global trials across therapeutic areas by acting as the primary Records Management SME, guiding teams through TMF lifecycle management in compliance with ICH-GCP, DIA TMF Reference Model, and client-specific SOPs.
• Analyzed TMF data metrics and completeness trends using customized dashboards and system-generated QC outputs, offering insight into artifact timeliness and implementing mitigations that reduced overdue documents by 22%.
• Authored and executed TMF Quality Plans for sponsor projects by aligning cross-functional documentation workflows, inspection readiness protocols, and remediation plans, supporting audit preparedness across all trial phases.
• Drove continuous process improvement initiatives such as standardized file review SOPs, TMF QC checklists, and eTMF metadata best practices, streamlining TMF quality review cycles and reducing rework by 30%.
• Managed a high-performing team of TMF specialists and analysts, assigning tasks, evaluating performance KPIs, conducting quarterly appraisals, and resolving operational escalations in accordance with IQVIAʼs HR policies.
• Represented the TMF Quality function as the primary EAC contact for designated project teams, ensuring stakeholder alignment, audit readiness, and regulatory inspection support during sponsor and authority reviews.

Apr 2016 – Jun 2018 · 2 yrs 2 mos

• Configured initial Wingspan eTMF environments for global Phase II–III studies by executing country wizards, creating study-specific placeholders, and provisioning user access for cross-functional teams, enabling rapid study activation timelines in compliance with sponsor SOPs and DIA reference model v3.
• Monitored project documentation by reviewing metadata accuracy, flagging incomplete or misclassified events, and collaborating with Clinical Leads, PMAs, and Project Leaders to ensure timely population of TMF artifacts across key milestones.
• Facilitated routine eTMF maintenance activities including study item creation, file review event setup, request list modifications, and metadata approvals, resulting in a 95% compliance score during internal QA checkpoint reviews.
• Executed comprehensive close-out procedures by running readiness reports, notifying stakeholders of pending deliverables, and initiating the final project lock process, improving first-pass final TMF submission accuracy.
• Supported ad hoc team requests through the development and cleanup of study-specific reports such as training compliance trackers, eTMF file review checklists, and communication folder audits, increasing eTMF review efficiency by 18%.

Aug 2013 – Mar 2016 · 2 yrs 7 mos · India

• Maintained electronic Trial Master Files (eTMF) and central regulatory files using PMED and Impact Harmony systems, executing version control and document integrity checks for global clinical research projects, in accordance with 21 CFR Part 11.
• Oversaw document lifecycle management by tracking, scanning, indexing, and uploading source data, CRFs, and regulatory documents across multiple therapeutic areas, ensuring alignment with client-specific SOPs and regulatory frameworks.
• Developed study-specific central file maintenance strategies for new trials, acted as the primary contact for cross-functional study teams, and resolved document inconsistencies through collaboration with Quality, Clinical Operations, and Data Management units.
• Facilitated training sessions for new associates on eTMF standards, EDC user provisioning, and deviation reporting protocols; escalated systemic quality issues to COLs/PLs via Impact Harmony, leading to 100% CAPA closure within defined timelines.

Jan 2012 – Jul 2013 · 1 yr 6 mos · India

• Coordinated end-to-end clinical trial documentation by maintaining regulatory-compliant essential files, including investigator EC approvals, CRF instructions, lab reference ranges, and SOP-compliant correspondence, ensuring audit readiness and traceability in adherence to ICH-GCP guidelines.
• Monitored clinical trial sites for protocol adherence, managed deviations through CAPA procedures, and facilitated real-time issue resolution with investigators, improving compliance scores during internal QA audits by 20%.
• Executed data management processes by validating completed CRFs, streamlining query resolution timelines, and implementing a structured data entry protocol to expedite database lock, thereby reducing data reconciliation cycles by 15%.
• Conducted rigorous internal QC checks on study-specific documentation using checklist-based evaluations aligned with sponsor SOPs, ensuring the completeness and accuracy of patient profiles, CSR summaries, and site master files.