Hire Gaurav

Gaurav Vacchani

Manager – Clinical Operations Delivery

Clinical Operations Manager with 11+ years of experience overseeing global clinical trial delivery, TMF operations, and cross-functional team leadership within pharmaceutical and CRO environments. Proven track record in improving study efficiency, enhancing TMF quality, and enabling audit readiness through process automation and data-driven decision-making. Demonstrated success in managing large operational teams, optimizing performance KPIs, and aligning study execution with ICH-GCP, regulatory, and sponsor expectations. Advanced expertise in Veeva Vault, CTMS, and process automation tools, with strong focus on operational excellence, stakeholder management, and continuous improvement. PMP certified.

FORMERLY AT

ThermoFisher Scientific

LOCATION

Bengaluru

AVAILABILITY

Full Time

Skills

CTMS

CTMS platforms

CTMS Systems

Excel Automation

MS Excel

Process Automation Tools

TMF analytics dashboards

TMF Metrics Reporting

TMF Quality Dashboards

Veeva Vault

Veeva Vault eTMF

Work Experience

Manager – Clinical Operations Delivery

ThermoFisher Scientific

Dec 2024 – Oct 2025

Directed Clinical Trial Coordinators supporting multiple global studies and increased workflow efficiency by 15%.
Standardized TMF workflows, improving study start-up timelines and reducing operational bottlenecks.
Ensured KPI-driven performance and maintained compliance with ICH-GCP and sponsor requirements.
Optimized resource allocation, workload distribution, and supported team hiring and onboarding.
Led continuous improvement initiatives aligned to global process consistency and automation.

TECHNOLOGIES

Veeva Vault eTMF, CTMS platforms, Process Automation Tools, MS Excel, TMF analytics dashboards

Deputy General Manager – Clinical Operations

Accenture Solutions Pvt. Ltd.

Sep 2022 – Nov 2024

Managed a team of 35+ and reduced attrition by 20% by implementing mentoring and capability building.
Increased TMF completeness by 25% using analytics and customized dashboards within Veeva Vault.
Implemented automation solutions resulting in reduced manual efforts and turnaround time.
Ensured continuous audit readiness, achieving 98% FTQ (First-Time Quality).
Partnered with executive leadership on metrics redesign and standardization of global TMF processes.

TECHNOLOGIES

Veeva Vault eTMF, TMF Metrics Reporting, Excel Automation, CTMS Systems, Process Automation Tools

Assistant Manager – Clinical Operations

Accenture Solutions Pvt. Ltd

Mar 2019 – Aug 2022

Oversaw TMF documentation and ensured compliance with ICH-GCP and sponsor SOPs.
Increased overall team productivity by 20% through KPI monitoring and targeted performance improvements.
Improved onboarding efficiency by 40% and documentation quality by 15%.
Supported performance reviews, workload balancing, and capacity planning.
Coordinated TMF/CTMS activities ensuring timely report submission and document reconciliation.