Looking for a job

mani vamsi

@manivamsi

I build risk-based quality management frameworks that improve clinical trial data quality, oversight, and operational efficiency.

India

Message

What I'm looking for

I'm looking to lead RBQM, clinical data management, and trial analytics initiatives where I can improve data quality, patient safety, regulatory compliance, and operational efficiency through standardized, data-driven risk management.

I've led RBQM, medical data review, and EDC delivery across Fortrea and IQVIA, building risk frameworks, KRIs, Spotfire visualizations, and clinical data review models that strengthen trial oversight and patient safety.

I've managed global teams of 15+ and 25+ people, delivered RBM implementation across 120+ studies, improved data quality metrics by 35%, and reduced database build timelines by 40% through standardization, automation, and process improvement.

Experience

Work history, roles, and key accomplishments

Manager, EDC Design & Programming

Fortrea

Feb 2021 - Jan 2025 (3 years 11 months)

Managed a cross-functional team of 15+ members across multiple geographies, overseeing EDC design, development, and global standards. Collaborated with vendors and stakeholders to deliver robust EDC databases and focused on budget realization and revenue generation.

EDC Design Medidata ECOA IRT Central Laboratory KPI Metrics Team Leadership Budget Management Stakeholder Management

Manager, Medical Data Review & Risk-Based Monitoring

IQVIA

May 2018 - Jan 2021 (2 years 8 months)

Served as primary Sponsor POC for RBM implementation across 120+ studies, establishing risk-based monitoring frameworks and Spotfire-based visualizations. Led operational risk management meetings and implemented process optimizations that enhanced operational efficiency by 30%.

Risk Based Quality Management Spotfire Medical Data Review Statistical Process Control Process Optimization Team Leadership Stakeholder Management

POC, SME | RBQM Analyst

IQVIA

Jan 2013 - Dec 2018 (5 years 11 months)

Led RBQM project delivery for Inflammation, Oncology, and Cardiovascular therapeutic areas, focusing on risk identification and quality management. Developed early-phase RBQM methodologies and conducted statistical analysis to support risk-based decision making.

RBQM Clinical Data Review Statistical Analysis Risk Identification Quality Management

Associate Scientist, Discovery Medicine & Clinical Pharmacology

Syngene International Ltd.

Jun 2011 - Dec 2012 (1 year 6 months)

Set up the FlowCytometry laboratory infrastructure with comprehensive quality management systems. Developed and standardized PBMC isolation protocols and trained team members on assay protocols.

Flow Cytometry PBMC Isolation Assay Development Quality Management Training

Medical Technologist II, Infectious Diseases Lab

ICON Central Laboratories

Dec 2008 - Apr 2011 (2 years 4 months)

Established Infectious Disease & Flow Cytometry Labs in Bangalore and Singapore with CAP and NABL standards. Implemented global standardization of instrument settings and calibration procedures, and managed quality control programs.

Infectious Disease Testing Flow Cytometry CAP Standards NABL Quality Standards Quality Control Calibration