Director, Clinical Data Management

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. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

The Director, Clinical Data Management, is responsible for executing strategic direction and ensuring effective end-to-end data management services across programs and studies. This role has primary leadership responsibility for the India-based CDM organization and is accountable for elevating the quality, consistency, and predictability of clinical data delivery, ensuring that projects meet or exceed established quality standards, timelines, and financial targets. A key focus of the role is to strengthen and mature the Clinical Data Management (CDM) function by enhancing leadership effectiveness, reinforcing core data management fundamentals, and implementing consistent operational oversight and best practices. The Director will also lead the development and scaling of a high-performing team of Clinical Data Management professionals, data analysts, and subject matter experts focused on ongoing data review, proactive data surveillance, and generation of meaningful customer insights.

In parallel, the Director will play a critical role in modernizing the organization’s data management capabilities through the adoption of risk-based methodologies, advanced analytics, centralized and AI-enabled data review, and other data-driven approaches aligned with broader business objectives. The role partners with internal and external stakeholders optimize data management technologies, processes, and standards while driving cross-functional collaboration to deliver scalable solutions that enhance operational effectiveness and customer value. As a Subject Matter Expert (SME), the Director also contributes to business growth through thought leadership, strategicconsulting, client engagement, and the advancement of differentiated data management and analytics capabilities.

KEY TASKS & RESPONSIBILITIES

• Provide strategic leadership for the India-based Clinical Data Management (CDM) organization, ensuring high-quality, consistent, and predictable delivery of end-to-end data management services across programs and studies.
• Drive the evolution and maturity of the CDM function by reinforcing data management fundamentals, and implementing standardized operational oversight, governance, and best practices.
• Drive process improvements, automation initiatives, and adoption of emerging technologies in clinical data management.
• Execute initiatives focused on modernizing data review and oversight processes through the use of data insights, analytics, and AI-enabled data review capabilities.
• Build a culture of quality, accountability, collaboration, and continuous improvement.
• Ensure all CDM activities are executed in compliance with SOPs, ICH/GCP guidelines, regulatory requirements, and applicable quality standards while maintaining inspection readiness.
• Establish, monitor, and report key operational metrics related to quality, productivity, cycle times, delivery predictability, and financial performance.
• Develop and implement continuous improvement initiatives to enhance efficiency and scalability.
• Oversee resource planning, talent development, organizational capability building, and succession planning to support current delivery needs and future business growth.
• Partner cross-functionally with other operational teams to optimize data management processes, standards, systems integration, and delivery models.
• Serve as a subject matter expert (SME) for Clinical Data Management, contributing to innovation initiatives, and development of scalable solutions that enhance customer value and operational effectiveness.
• Support business development activities through thought leadership, strategic consulting, client presentations, proposal support, and participation in sponsor engagements
• Foster strong client relationships by promoting a customer-centric culture focused on quality execution, transparency, responsiveness, and long-term partnership growth.
• Provide regular operational and strategic updates to executive leadership regarding delivery performance, organizational health, risks, opportunities, and strategic initiatives.
• Perform other duties and strategic initiatives as assigned.

Education:

• Minimum of 15 years of progressive experience in Clinical Data Management within CRO, pharmaceutical, biotechnology, or medical device environments, including leadership of global clinical data management operations and delivery teams preferred.
• Bachelor of Science degree / Master of Science, in Life Sciences, Health Sciences, Pharmacy,Nursing, Biotechnology, or a related scientific discipline preferred.

Professional Skills:

• Strong strategic leadership capabilities with the ability to drive organizational transformation, operational excellence, and scalable delivery models within Clinical Data Management.
• Demonstrated ability to drive adoption of innovative technologies, including AI-enabled data review, analytics-driven oversight, and automation solutions that enhance quality, efficiency, and operational scalability.
• Strong experience with Clinical Data Management systems, EDC platforms, and other clinical data acquisition technologies.
• Excellent leadership, mentoring, and talent development skills with experience building and scaling high-performing delivery teams and future leaders.
• Demonstrated experience managing complex client relationships requiring multiple DM services and projects.
• Proven ability to establish and monitor operational metrics, identify trends and risks, and implement data-driven process improvements.
• Strong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation
• Strong prior customer interface experience with a demonstrated ability to develop, maintain and grow strong Client relationships.
• A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first.
• Excellent verbal and written communication skills

Technical Skills & Experience:

• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Experience with EDC and Clinical Data Management Systems: Medidata Rave is preferred.
• Experience with clinical data reporting, visualization, and analytics platforms used to support operational insights, quality oversight, and proactive risk identification.
• Familiarity with AI-enabled data review capabilities, automation technologies, and emerging innovations within Clinical Data Management.
• 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 preferred.
• Proficiency in Microsoft Office Applications.

 

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We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.