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)
