KASHIVISHWANATH ROUTHU
Summary
Senior Manager with 16+ years of experience leading Clinical Database Programming functions for global clinical trials. Proven track record of leading a 18 member team, delivering severalclinical studies, partnering with sponsors, driving operational excellence, resource planning, inspection readiness, and mentoring high-performing teams. Recognized with the Country Head Recognition Award for outstanding leadership and business impact.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Senior Manager
Parexel
07.2025 - Current
Manager
Parexel
03.2022 - 06.2025
Senior Principal Clinical Database Programmer
Parexel
04.2021 - 02.2022
Principal Clinical Database Programmer
Parexel
05.2016 - 03.2021
Senior Clinical Database Programmer
Parexel
07.2013 - 04.2016
Process Associate – CRF Designer
Accenture
05.2010 - 09.2011
Education
M.Sc. - Bioinformatics
University of Madras
B.Sc. - Biotechnology
Osmania University
Skills
- People Leadership & Coaching
- Stakeholder & Sponsor Management
- Learning & Development
- Training Representative
- Clinical Database Programming
- ECRF Design
- Study Build & Validation
- Edit Check Programming
- Resource Planning & Allocation
- Performance Metrics & Leadership Reporting
- Operational Excellence
- Continuous Improvement
- Vendor Collaboration
- Inspection Readiness
- ICH-GCP Compliance
Accomplishments
- Lead and mentor a team of 18 Clinical Database Programming professionals.
- Successfully led and delivered multiple global clinical studies.
- Serve as Training Representative and delivered 15+ departmental training sessions.
- Lead five departmental and cross-functional improvement initiatives.
- Own KPI dashboards and leadership metrics reporting.
- Lead technical interviews and hiring activities for the programming function.
- Manage resource forecasting, allocation, and capacity planning.
- Review pricing assumptions and provide proposal support.
- Coordinate with sponsors and support audit and inspection readiness.
- Collaborate with technology vendors to enhance platform capabilities.
Certification
- Medidata Rave Certified Study Builder
- IBM Clinical Development Certified Designer
- DataLabs Certified Designer
- TrialGrid
- Metadata Repository (MDR)
- Hudson Institute Certified Spot Coach
Timeline
Senior Manager
Parexel
07.2025 - Current
Manager
Parexel
03.2022 - 06.2025
Senior Principal Clinical Database Programmer
Parexel
04.2021 - 02.2022
Principal Clinical Database Programmer
Parexel
05.2016 - 03.2021
Senior Clinical Database Programmer
Parexel
07.2013 - 04.2016
Process Associate – CRF Designer
Accenture
05.2010 - 09.2011
M.Sc. - Bioinformatics
University of Madras
B.Sc. - Biotechnology
Osmania University