Director, Clinical Data Management

About the Company

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials.

Responsibilities

• Provide strategic leadership for the India-based Clinical Data Management (CDM) organization
• Drive the evolution and maturity of the CDM function through standardized operational oversight and governance
• Execute initiatives to modernize data review using analytics and AI-enabled capabilities
• Ensure all CDM activities comply with SOPs, ICH/GCP guidelines, and regulatory requirements
• Establish and monitor key operational metrics related to quality, productivity, and financial performance
• Oversee resource planning, talent development, and succession planning
• Support business development through thought leadership, strategic consulting, and client engagement

Requirements

• Minimum of 15 years of progressive experience in Clinical Data Management within CRO, pharmaceutical, biotech, or medical device environments
• Experience leading global clinical data management operations and delivery teams
• Strong experience with Clinical Data Management systems and EDC platforms
• Proven ability to manage complex client relationships and multiple DM projects
• Strong project management skills including scope, resource, and financial management
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology
• Proficiency in Microsoft Office Applications

Preferred Qualifications

• Bachelor of Science or Master of Science in Life Sciences, Health Sciences, Pharmacy, Nursing, Biotechnology, or a related scientific discipline
• Experience with Medidata Rave
• Familiarity with AI-enabled data review, automation technologies, and Risk-Based Quality Management (RBQM)