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Shashikant Visave
Manager – Clinical Operations Delivery
Manager – Clinical Operations Delivery
Shashikant Visave is a Clinical Operations Manager with 11+ years of experience in global clinical research, TMF oversight, and operational excellence across pharma and CRO environments. He specializes in process automation, KPI-driven performance management, and inspection readiness under ICH-GCP. With expertise in Veeva Vault, project leadership, and continuous process improvement, Shashikant drives TMF quality, team productivity, and streamlined study execution.
FORMERLY AT
Thermo Fisher Scientific
LOCATION
Bangalore, India
AVAILABILITY
Full-time
Skills
Audit/Compliance Tracking
Audit/Inspection Readiness
CTA Submission Support
KPI Dashboarding
KPI Tracking
Operational Efficiency
Process Automation
Resource Allocation
TMF Setup/Reconciliation/QC
TMF Workflow Optimization
Veeva Vault eTMF
Work Experience
Deputy General Manager – Clinical Operations
Accenture Solutions Pvt. Ltd.,
September 2022 – November 2024
- Led TMF operations and strategic initiatives for clinical studies, overseeing a team of 35+ TMF Managers/Analysts.
- Increased TMF completeness by 25% via customized KPI dashboards and improved FTQ to 98%. Implemented automation initiatives reducing manual efforts and improved operational efficiency and revenue by 15%.
- Supported global audits (MHRA, PMDA Japan) with zero TMF-related observations.
TECHNOLOGIES
Veeva Vault eTMF, KPI Dashboarding, Process Automation, Audit/Inspection Readiness
Assistant Manager – Clinical Operations
Accenture Solutions Pvt. Ltd
March 2019 – August 2022
- Oversaw TMF documentation processes ensuring ICH-GCP and sponsor SOP compliance.
- Increased team productivity by 20% through KPI monitoring and workflow improvements. Trained TMF Managers/Analysts and enhanced documentation accuracy by 15%. Maintained continuous inspection readiness across multiple global trials.
TECHNOLOGIES
TMF QC, Workflow Optimization, KPI Tracking, Resource Planning
Clinical Document Specialist
Accenture Solutions Pvt. Ltd.,
May 2016 – February 2019
- Managed TMF setup, quality control, reconciliation, and compliance tracking.
- Designed TMF structures aligned to reference models and oversaw CTA submissions to Health Authorities/IRBs.
- Participated in MHRA/PMDA/client audits with zero findings and conducted onboarding and training for new specialists.
TECHNOLOGIES
TMF Setup/Reconciliation/QC, CTA Submission Support, Audit/Compliance Tracking
