Job Description
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.
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)
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
