Principal Clinical Data Manager
Clinical Outcomes Solutions
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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.
- Develop and implement SOPs and interactive process maps that provide a comprehensive overview of the data management lifecycle.
- 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.
- Partner with Data Management leaders and cross-functional workstream groups to define deliverables and ensure alignment with broader program goals.
- Ensure all processes and deliverables meet regulatory requirements and internal quality standards.
- Supports audit readiness and continuous improvement initiatives.
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.
Benefits
- Comprehensive and competitive total reward package
- World class employee benefits
- Supportive policies
- Wellbeing initiatives tailored to support you and your family
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data managementSOP writingprocess developmentEDC systemsdata cleaningquery managementclinical codingSAE reconciliationblinding proceduresdatabase lock
Soft Skills
communicationorganizational skillsproblem-solvingcollaborationleadership