Principal Clinical Data Manager
- Process Reengineering & Oversight:
- Collaborate on the redesign of end-to-end data management processes to support internal execution, including study start-up, maintenance, and close-out.
- Evaluate and revise existing procedures to align with internal capabilities, ensuring efficiency, compliance, and scalability.
- SOP & Process Flow Development:
- Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
- Ensure documentation reflects best practices and supports cross-functional understanding and training.
- Functional Area Ownership:
- Oversee the reengineering of critical data management functions, including:
- Study Set-Up
- EDC Build and Maintenance
- Data Cleaning and Query Management
- Local Lab and External Data Handling
- Clinical Coding
- SAE Reconciliation
- Blinding Procedures
- Site Close-Out and Database Lock
- DM Metrics and Clean Patient Tracker
- Oversee the reengineering of critical data management functions, including:
- Cross-Functional Collaboration:
- Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
- Provide subject matter expertise and strategic input to support project planning and execution.
- Quality & Compliance:
- Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
- Support audit readiness and continuous improvement initiatives.
- Following project completion may transition into a hands-on Clinical Data Manager Role, where responsibilities may include but not be limited to:
- Represents data management function on the clinical trial working group, ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions.
- Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
- Contributes influential leadership in collaboration with other client stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
- Ensures achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Statistical Programming and Statistics.
- Contributes to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Bachelor’s degree in Life Sciences, Health Informatics, or related field
- 10+ years of progressive experience in clinical data management, with significant experience in a leadership or principal-level role.
- Proven expertise in process development, SOP writing, and cross-functional collaboration.
- Strong knowledge of EDC systems, CDISC standards, and regulatory requirements.
- Excellent communication, organizational, and problem-solving skills.
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