Prasanth Kumar P M
Summary
Accomplished Clinical Data Management and Transformation Leader with over 20 years of expertise in clinical development, data management, and process transformation. Led complex global transitions while ensuring data integrity, regulatory compliance, and business continuity. Collaborated effectively with senior leaders, study teams, and vendors to enhance governance, risk management, and operational efficiency.
Overview
22
22
years of professional experience
Work History
Director, Clinical Data Projects - Secondment
AstraZeneca
07.2025 - Current
- Provide strategic oversight across multiple concurrent global studies, managing priorities, dependencies, risks, and delivery performance.
- Partner with senior leadership, study teams, technology stakeholders, CROs, and external partners to resolve complex operational issues and accelerate transformation outcomes.
- Lead global clinical study transformation and transition initiatives spanning processes, systems, teams, and external partners, with accountability for continuity, quality, compliance, and delivery.
- Drive process optimization, automation, standardization, and continuous improvement to strengthen scalability, productivity, and operational efficiency.
- Lead enterprise-level risk, quality, compliance, and operational controls across large-scale transformation programs.
- Developed governance frameworks, operating models, transition roadmaps, standardized processes, and performance-management mechanisms to align initiatives with strategic objectives.
- Established executive dashboards and KPI frameworks to monitor portfolio performance, transition readiness, risks, and strategic outcomes.
- Led people reporting and performance management initiatives, coaching, mentoring, and building capabilities to enhance career development and succession planning.
Associate Director, Clinical Data Projects - Secondment
AstraZeneca
09.2024 - 06.2025
- Directed cross-functional teams and vendor partnerships through large-scale migrations while managing business and delivery risks.
- Developed governance frameworks, transition timelines, and stakeholder communication models to enhance execution and facilitate informed decision-making.
- Delivered process transformation initiatives that automated workflows and improved operational effectiveness.
- Delivered process transformation initiatives focused on automation and operational improvement.
- Established executive dashboards and performance metrics to monitor transitions and support leadership decisions.
Associate Director, Clinical Data Management
AstraZeneca
09.2022 - 09.2024
- Led Clinical Data Management activities across multiple studies, ensuring timely, high-quality, compliant data delivery.
- Ensured data quality, consistency, and database integrity by resolving issues proactively and adhering to CDM standards.
- Coordinated cross-functional CDM deliverables, aligning standards, processes, systems, timelines, and study objectives.
- Acted as primary Data Management vendor contact and key contributor to Global Study Teams.
- Served as primary Data Management vendor contact and key contributor to Global Study Teams.
- Chaired stakeholder meetings, communicating study progress, risks, and key insights to inform leadership decisions.
Associate Director - CDM Functional Lead
Novartis Healthcare Pvt. Ltd.
04.2018 - 09.2022
- Served as Global Business Process Owner for eSAE, driving process standardization, governance, continuous improvement, and global adoption.
- Acted as Global Business Process Owner for eSAE, standardizing processes and enhancing governance for global adoption and continuous improvement.
- Led automated eSAE data transmission and end-to-end monitoring from RAVE EDC to Argus, strengthening safety-data accuracy, traceability, and reliability.
- Streamlined data collection and CRF standardization through protocol review and harmonization of CDM practices.
- Optimized data collection and CRF standardization through protocol review and harmonized CDM practices.
- Authored and maintained SOPs, policies, process guidance, training materials, and operational documentation.
- Led recruitment, onboarding, people reporting, performance management, and capability development of Data Management teams.
- Chaired cross-functional forums, leveraging performance metrics and operational insights to formulate actionable recommendations and drive improvements.
Earlier Clinical Data Management Roles
Novartis Healthcare Pvt. Ltd.
01.2009 - 01.2018
- Delivered Data Management for global clinical trials from study start-up through database lock, including clinical database design, data review and cleaning, data quality, eCRF/DRP standardization, DMP development, process governance, and regulatory compliance.
- Collaborated with Clinical, Biostatistics, Programming, CROs, vendors, and global stakeholders to deliver timely, high-quality, analysis-ready data.
- Coordinated with Clinical, Biostatistics, Programming, CROs, vendors, and global stakeholders to ensure timely delivery of high-quality, analysis-ready data.
- Developed expertise in process optimization, stakeholder management, people development, training, and standardized Data Management practices across studies and programs, enhancing overall data management quality.
Junior Data Manager
SIRO Clinpharm Pvt. Ltd.
Mumbai
01.2005 - 01.2009
- Developed expertise in clinical data management with over 3 years of experience supporting various clinical data management activities before joining Novartis.
- Managed data collection processes for clinical trials and research studies.
- Developed and maintained databases to ensure data integrity and accuracy.
- Collaborated with cross-functional teams to support project needs and requirements.
Education
Bachelor of Pharmacy -
Rajiv Gandhi University of Health Sciences
BangaloreDiploma of Pharmacy -
Board of Examining Authority
BangaloreSkills
- Clinical Data Management
- Clinical Data Transformation
- Data Quality & Integrity
- Regulatory Compliance
- Clinical Data Standards
- RAVE EDC
- Oracle Clinical (OCRDC)
- Database design
- Process Excellence
- Project Transition Oversight
- Risk and Issue Management
- Vendor Management
- Cross-Functional Leadership
- Operational Strategy
- Program oversight
- Stakeholder Management
- Leadership development
Accomplishment
- Redefining Clinical Data Flow - Transition Lead : Led migration and transition of global clinical studies across legacy and next-generation processes and systems; established governance, readiness, risk controls, and performance monitoring to support continuity and transformation.
- ESAE Business Lead : Led automated eSAE transmission within RAVE EDC with end-to-end SAE data-flow monitoring to Argus; served as Global eSAE Business Process Owner driving standardization, governance, and continuous improvement.
- Regulatory & Inspection Readiness: Served as business lead for audits and Health Authority inspections involving FDA, Swissmedic, EMA, and MHRA; supported CAPA development and established inspection-readiness and simulation practices.
- Process & Quality Excellence: Contributed to third-party data-transfer specifications, eSAE guidance, SOPs, training materials, and study-level Data Management documentation; strengthened proactive data-quality and database-lock risk management.
- People & Capability Development: Led recruitment, onboarding, performance management, coaching, mentoring, capability development, and succession planning; identified capability gaps and supported targeted development initiatives.
- Vendor & Stakeholder Leadership: Managed Clinical Data Management and third-party data vendors and partnered with senior stakeholders, study teams, technology groups, CROs, and cross-functional functions to deliver complex programs.
Timeline
Director, Clinical Data Projects - Secondment
AstraZeneca
07.2025 - Current
Associate Director, Clinical Data Projects - Secondment
AstraZeneca
09.2024 - 06.2025
Associate Director, Clinical Data Management
AstraZeneca
09.2022 - 09.2024
Associate Director - CDM Functional Lead
Novartis Healthcare Pvt. Ltd.
04.2018 - 09.2022
Earlier Clinical Data Management Roles
Novartis Healthcare Pvt. Ltd.
01.2009 - 01.2018
Junior Data Manager
SIRO Clinpharm Pvt. Ltd.
01.2005 - 01.2009
Bachelor of Pharmacy -
Rajiv Gandhi University of Health Sciences
Diploma of Pharmacy -
Board of Examining Authority