Director, Clinical Data Management

About the role

eClinical Solutions is seeking a Director of Clinical Data Management to lead its India‑based CDM organization. The role will drive strategic direction, elevate data quality, and modernize data management through risk‑based and AI‑enabled approaches.

Key responsibilities

• Provide strategic leadership for end‑to‑end clinical data management services across programs and studies.
• Drive maturity of the CDM function by implementing standardized governance, process improvements, automation, and emerging technologies.
• Ensure compliance with SOPs, ICH/GCP, 21 CFR Part 11 and maintain inspection readiness.
• Monitor and report operational metrics such as quality, productivity, cycle times, and financial performance.
• Oversee resource planning, talent development, succession planning and build high‑performing delivery teams.
• Partner with cross‑functional teams and clients to optimize data management processes and deliver scalable solutions.

Required profile

• Minimum 15 years of progressive experience in Clinical Data Management within CRO, pharmaceutical, biotechnology or medical device environments.
• Bachelor’s or Master’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing, Biotechnology or related scientific discipline.

Required skills

• Strong knowledge of ICH/GCP guidelines and 21 CFR Part 11.
• Experience with Clinical Data Management systems and EDC platforms, preferably Medidata Rave.
• Familiarity with AI‑enabled data review, analytics‑driven oversight and automation technologies.
• Understanding of Risk‑Based Quality Management (RBQM) and Risk‑Based Monitoring (RBM) methodologies.
• Proficiency in Microsoft Office applications.