Principal Clinical Data Manager

The Principal Clinical Data Manager (Sponsor-Dedicated) works fully embedded within a global pharmaceutical client, serving as the lead data management representative across assigned clinical studies. This role is responsible for overseeing end-to-end clinical data management processes, driving process reengineering initiatives, ensuring regulatory compliance, and delivering high-quality data in support of key decision points and regulatory submissions. The position combines strategic leadership with hands-on data management execution.

Responsibilities & Duties:

Process Reengineering & Oversight

• Collaborate on the redesign and optimization of end-to-end data management processes including study start-up, maintenance, and close-out.
• Evaluate and revise existing procedures to align with internal execution capabilities, ensuring operational efficiency, compliance, and scalability.
• Provide strategic oversight of functional improvements across data management operations.

Functional Area Ownership

Oversee and contribute to the reengineering and execution of critical data management functions, including:

• Study Set-Up
• EDC Build and Maintenance
• Data Cleaning and Query Management
• Local Laboratory and External Data Handling
• Clinical Coding
• SAE Reconciliation
• Blinding Procedures
• Site Close-Out and Database Lock
• Data Management Metrics and Clean Patient Tracker oversight

Quality & Compliance

• Ensure all data management activities comply with applicable regulatory requirements, CDISC standards, and internal quality standards.
• Support audit readiness, inspection preparedness, and continuous quality improvement initiatives.
• Identify and mitigate data-related risks proactively.

Clinical Trial Leadership & Cross-Functional Collaboration

• Represent the Data Management function within the clinical trial working group.
• Ensure aligned expectations for all data-related deliverables, especially those supporting regulatory submissions and key milestone decisions.
• Collaborate closely with Clinical Operations, Statistical Programming, Biostatistics, and other stakeholders to ensure timely database lock and delivery of high-quality data.
• Provide influential leadership to ensure milestones and deliverables are met within timelines and budget.
• Contribute to continuous improvement initiatives at the functional and organizational levels.

Requirements:
• Bachelor’s degree in Life Sciences, Health Informatics, or related field
• Minimum of 5 years of progressive experience in clinical data management
• Demonstrated experience in end-to-end study data management (start-up through database lock)
• Proven expertise in process development, SOP writing, and process reengineering
• Strong knowledge of EDC systems and clinical data workflows
• Solid understanding of CDISC standards and global regulatory requirements
• Experience working cross-functionally within global clinical trial teams

Preferred Qualifications (Optional):

• Experience in sponsor-dedicated or fully embedded pharmaceutical environments
• Experience leading or mentoring junior data managers
• Experience supporting regulatory submissions (e.g., NDA, BLA, MAA)
• Experience with risk-based monitoring environments

Educational Requirements & Certifications:

• Bachelor’s degree in Life Sciences, Health Informatics, or related field (required)
• Advanced degree (Master’s) in related discipline (preferred)
• CDISC certification or related industry certification (preferred)

Benefits:
• HMO with 1 free dependent upon hire
• Life Insurance
• 10% Night Differential
• 20 PTO credits annually
• Annual Performance-Based Merit Increases and Employee Recognition
• Great Company Culture
• Career Growth and Learnings
• Night Shift
• Work from Home