About the job
Join our dynamic team as a Principal Clinical Data Manager, where you will be intricately involved with a leading global pharmaceutical client. This vital role places you at the forefront of clinical studies as the primary data management representative. Your expertise will guide the end-to-end clinical data management processes, spearhead innovative process reengineering initiatives, and ensure adherence to regulatory standards while delivering precise data to facilitate key decision-making and regulatory submissions. This position uniquely combines strategic leadership with practical data management execution.
Key Responsibilities:
Process Reengineering & Oversight
- Collaborate in the redesign and optimization of comprehensive data management processes, covering study initiation, ongoing management, and closure.
- Assess and refine existing protocols to align with internal capabilities, ensuring operational efficiency, compliance, and scalability.
- Provide strategic direction for functional enhancements across data management operations.
Functional Area Ownership
Oversee and actively engage in the reengineering and execution of crucial 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
- Monitoring Data Management Metrics and Clean Patient Tracker
Quality & Compliance
- Ensure all data management activities adhere to relevant regulatory requirements, CDISC standards, and internal quality benchmarks.
- Support initiatives for audit readiness, inspection preparedness, and continual quality improvement.
- Proactively identify and mitigate data-related risks.
Leadership in Clinical Trials & Cross-Functional Collaboration
- Act as the representative for Data Management within the clinical trial working group.
- Align expectations for all data deliverables, particularly those essential for regulatory submissions and milestone decisions.
- Work 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 meet milestones and deliverables within established timelines and budget.
- Contribute to ongoing improvement initiatives at both functional and organizational levels.

