GIRISH J RAO

Extensive experience in strategic planning, project management, and stakeholder communication within Clinical Data Management and Biostatistics. Demonstrated track record of leading cross-functional teams through all phases of clinical data lifecycle — from protocol design, data collection and validation, to database lock and statistical analysis. Skilled in developing project plans, risk mitigation strategies, and timeline and resource forecasts to ensure on-time, on-budget delivery.

Strong command of regulatory requirements (ICH-GCP, FDA/EMA/NMPA/PMDA guidelines) and data standards (CDISC - SDTM/ADaM), enabling compliant and efficient data deliverables.

Recognized for adaptability in fast-paced environments, decisive problem-solving under competing priorities, and a results-oriented approach that consistently improves operational efficiency and supports successful organizational outcomes.

• Led the "Work Allocation Project" within Accenture Services Pvt. Ltd., standardizing time-to-resource management and increasing operational transparency across functions.
• Spearheaded organization-wide adoption of SDTM programming at Novo Nordisk in 2016, establishing a centralized capability that accelerated data standardization and improved cross-study consistency.
• Designed and automated resource-forecasting tool and upgraded the resourcing dashboard, reducing forecast time and enhancing leadership visibility for staffing decisions.
• Developed a unit-level risk management framework to identify, quantify, and mitigate operational and infrastructure risks, enabling early detection and prevention of potential service disruptions.
• Defined and operationalized metrics for non-trial activities in collaboration with Regulatory Affairs, Medical Science, and Trial Management, enabling objective performance tracking and resource prioritization.
• Contributed to SOP rationalization as part of an SOP-reduction team by challenging low-value processes and eliminating redundancies, streamlining procedures to focus on core activities.
• Facilitated multiple team-engagement and innovation workshops to strengthen team dynamics, increase collaboration, and generate actionable ideas.
• Established partnerships with universities and industry peers to create talent pipelines and structured knowledge-sharing initiatives, enhancing recruitment and professional development.

• Passport Number: Z3916417
• Father's Name: L. Jagadeesha
• ID Type: Passport
• ID Number: Z3916417
• Date of Birth: 27-January-1986
• Marital Status: Married

Six sigma (cLean)