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Comprehensive BPO, RPO, and Call Center Outsourcing Solutions for Growing Businesses
Principal Clinical Data Manager
Location
United States
Posted
107 days ago
Salary
0
Seniority
Lead
Job Description
Principal Clinical Data Manager
SuperStaff
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.
Job 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)
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