Director, Clinical Data Management

The role

The Director, Clinical Data Management provides strategic leadership for the India-based CDM organization. This role ensures effective end-to-end data management services and modernizes capabilities through AI-enabled review and advanced analytics.

What you will do

• Provide strategic leadership for the India-based Clinical Data Management organization.
• Drive the evolution and maturity of the CDM function.
• Drive process improvements, automation initiatives, and adoption of emerging technologies.
• Execute initiatives to modernize data review and oversight processes using AI and analytics.
• Ensure CDM activities comply with SOPs, ICH/GCP guidelines, and regulatory requirements.
• Establish, monitor, and report key operational metrics.
• Oversee resource planning, talent development, and succession planning.
• Partner cross-functionally to optimize data management processes and systems.
• Serve as a subject matter expert for Clinical Data Management.
• Support business development through thought leadership and client engagement.

Required qualifications

• Minimum of 15 years of progressive experience in Clinical Data Management within CRO, pharmaceutical, biotechnology, or medical device environments.
• Strong strategic leadership capabilities.
• Ability to drive adoption of innovative technologies including AI-enabled data review and automation.
• Experience with Clinical Data Management systems and EDC platforms.
• Experience building and scaling high-performing delivery teams.
• Experience managing complex client relationships.
• Ability to establish and monitor operational metrics.
• Strong project management skills including scope, resource, and financial management.
• Prior customer interface experience.
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology.
• Experience with clinical data reporting, visualization, and analytics platforms.
• Proficiency in Microsoft Office Applications.

Nice to have

• Leadership of global clinical data management operations and delivery teams
• Bachelor of Science degree / Master of Science, in Life Sciences, Health Sciences, Pharmacy, Nursing, Biotechnology, or a related scientific discipline
• Medidata Rave
• Familiarity with AI-enabled data review capabilities and automation technologies
• Understanding of Risk-Based Quality Management (RBQM), Risk-Based Monitoring (RBM), centralized data review, and analytics-driven oversight methodologies
• Experience with project planning, resource forecasting, financial tracking, and operational performance management tools

About the company

eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. It is a people first organization with an inclusive culture.