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.