SUDHINDRA NAMANNA
Summary
Senior Clinical Data Management (CDM) leader with 15+ years of global experience delivering end-to-end data management for complex clinical studies across multiple operating models (in‑house and CRO). Proven ability to serve as first line of contact at study level, lead DM vendors, anticipate and mitigate risks, and ensure inspection-ready, high‑quality data delivery on time and within budget. Strong expertise in DM governance, performance oversight, analytics-driven decision making, and mentoring high‑performing teams
Overview
20
20
years of professional experience
1
1
Certification
Work History
Manager – Data Management
GSK Pharma
Bengaluru, KA
12.2021 - Current
- Accountable for end‑to‑end Clinical Data Management delivery at study level, serving as the primary DM point of contact for assigned studies across start‑up, conduct, and database lock.
- Lead and govern DM vendors and CRO partners, providing direction to Lead Data Managers/DM Team Leads to ensure consistent, high‑quality outcomes aligned to study timelines and objectives.
- Identify operational and delivery risks early, collaborate with vendors on mitigation strategies, and escalate critical issues to protect study integrity and timelines.
- Drive adherence to DM standards, SOPs and regulatory requirements, ensuring data consistency, usability and readiness for downstream analysis.
- Lead DM inspection readiness activities, contributing expert input to regulatory inspections and audits and ensuring robust documentation and process compliance.
- Ensure DM documentation compliance with Trial Master File (TMF) requirements, aligned to operating model and vendor responsibilities.
- Oversee DM vendor performance against KPIs, timelines and budgets; review billing accuracy and provide recommendations for invoice approval.
Senior Clinical Data Management Scientist (Protocol Data Manager)
Accenture Life Sciences
Bengaluru, KA
10.2018 - 12.2021
- Served as study-level DM lead and primary contact for day‑to‑day clinical data management activities.
- Provided oversight and guidance to DM teams, ensuring alignment with sponsor standards and study timelines.
- Directed eCRF design, edit check specifications, database build, testing and UAT, ensuring high data quality from first patient in.
- Led risk identification and issue resolution, escalating critical concerns to stakeholders as required.
- Certified Sponsor 'Train‑the‑Trainer' for Medidata Rave, mentoring and developing 10+ data managers.
Data Team Lead
Quintiles Technologies Ltd (IQVIA)
Bengaluru, KA
10.2015 - 07.2017
- Led DM teams and coordinated database set‑up and on‑study data management activities.
- Developed and managed DM timelines, monitored progress and proactively addressed risks impacting delivery.
- Prepared and executed UAT strategies, including test plan development and execution for EDC systems.
- Reviewed operational metrics, generated study status reports and ensured adherence to quality and delivery expectations.
Senior Clinical Data Coordinator
Quintiles Technologies Ltd (IQVIA)
Bengaluru, KA
03.2006 - 10.2015
- Delivered hands‑on clinical data management support, including data review, query management and issue resolution.
- Supported Data Team Leads and functioned as backup DTL, contributing to study continuity and risk mitigation.
- Built strong cross‑functional relationships with clinical and operational teams to ensure high‑quality data outcomes.
Education
Post Graduate - undefined
Emergency Medicine
01.2005
Bachelor of Ayurvedic Medicine & Surgery (BAMS) - undefined
01.2004
Skills
Team leadership
Documentation and reporting
Project management
Vendor management
Teamwork and collaboration
Certification
- GCP – Fundamentals (Barnett Accreditation)
- Project Management Certification – CADD Institute
- Japanese Language Proficiency Test (JLPT) – N3
Languages
English
Kannada
Hindi
Core Capabilities
- Study-Level DM Leadership & Ownership
- DM Vendor Partnership & CRO Oversight
- Risk Identification, Mitigation & Issue Escalation
- Data Standards, SOP & Quality Stewardship
- Inspection Readiness & Audit Support
- Trial Master File (TMF) Compliance
- Budget & Invoice Oversight
- Continuous Improvement & Operating Model Change
- Mentorship, Collaboration
Technology And Tools
Medidata Rave, Inform, Veeva CDMS, Spotfire, Power BI, JReview, MS Excel, PowerPoint, Word, MS Project
Personal Information
Title: Manager – Data Management
Timeline
Manager – Data Management
GSK Pharma
12.2021 - Current
Senior Clinical Data Management Scientist (Protocol Data Manager)
Accenture Life Sciences
10.2018 - 12.2021
Data Team Lead
Quintiles Technologies Ltd (IQVIA)
10.2015 - 07.2017
Senior Clinical Data Coordinator
Quintiles Technologies Ltd (IQVIA)
03.2006 - 10.2015
Post Graduate - undefined
Emergency Medicine