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Director, Clinical Data Management

1 month, 2 weeks ago
India
Full-time
Executive
Program Manager
Data Science and Analytics
Apply Now
eClinical Solutions

eClinical Solutions

eClinical Solutions is a leading provider of clinical data management solutions, offering software and services that enable organizations to maximize the value of their clinical data. Their elluminate platform empowers users with complete access to sta...

Professional Services
251-1K
Founded 2006
View All Jobs 10

Description

  • Provide strategic leadership for the India-based Clinical Data Management organization and ensure consistent end-to-end delivery across programs and studies.
  • Strengthen and mature the CDM function by reinforcing data management fundamentals, governance, and operational best practices.
  • Drive process improvements, automation initiatives, and adoption of emerging technologies in clinical data management.
  • Modernize data review and oversight through analytics, centralized review, and AI-enabled data review capabilities.
  • Build a culture of quality, accountability, collaboration, and continuous improvement.
  • Ensure CDM activities comply with SOPs, ICH/GCP guidelines, regulatory requirements, and applicable quality standards.
  • Establish, monitor, and report operational metrics covering quality, productivity, cycle times, delivery predictability, and financial performance.
  • Oversee resource planning, talent development, organizational capability building, and succession planning.
  • Partner cross-functionally to optimize data management processes, standards, systems integration, and delivery models.
  • Serve as a subject matter expert on Clinical Data Management and support business development through thought leadership, client engagement, and proposal support.

Requirements

  • Minimum of 15 years of progressive experience in Clinical Data Management within CRO, pharmaceutical, biotechnology, or medical device environments.
  • Experience leading global clinical data management operations and delivery teams is preferred.
  • Bachelor of Science or Master of Science in Life Sciences, Health Sciences, Pharmacy, Nursing, Biotechnology, or a related scientific discipline is preferred.
  • Strong strategic leadership capabilities with experience driving organizational transformation and scalable delivery models.
  • Demonstrated ability to drive adoption of AI-enabled data review, analytics-driven oversight, and automation solutions.
  • Strong experience with Clinical Data Management systems, EDC platforms, and other clinical data acquisition technologies.
  • Experience managing complex client relationships across multiple data management services and projects.
  • Proven ability to establish and monitor operational metrics and implement data-driven process improvements.
  • Strong project management skills, including scope, resource, financial, and project planning management.
  • 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 is preferred.
  • Familiarity with RBQM, RBM, centralized data review, and analytics-driven oversight methodologies.
  • Experience with project planning, resource forecasting, financial tracking, and operational performance management tools is preferred.
  • Proficiency in Microsoft Office applications.
  • Excellent verbal and written communication skills.

Interested in this position?

Apply directly on the company website

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