Senior Manager, Clinical Data Management

Senior Manager, Clinical Data Management

$140,000 - $180,000

Remote (U.S.)

Overview

A growing clinical-stage medical technology organization is seeking a Senior Manager of Clinical Data Management to lead and expand its internal data management capabilities. This is a highly visible leadership role responsible for overseeing clinical trial data quality, developing scalable processes, managing a small team of data management professionals, and partnering cross-functionally to ensure study data is accurate, audit-ready, and prepared for regulatory submissions. The individual will serve as a key stakeholder across Clinical Operations, Monitoring, Biostatistics, and external service providers while helping build a best-in-class clinical data infrastructure.

Key Responsibilities

• Lead, mentor, and develop a team of clinical data management professionals, providing direction on priorities, performance, and career growth.
• Oversee all data management activities across ongoing clinical studies, including data review, discrepancy management, reconciliation processes, and database lock preparation.
• Act as the primary internal expert for electronic data capture (EDC) platforms and collaborate with external vendors on system implementation, maintenance, enhancements, and user acceptance testing.
• Establish and maintain Data Management Plans, data review strategies, standards documents, SOPs, and operational procedures.
• Partner closely with Clinical Operations and study teams to monitor data quality, protocol compliance, site performance, and study milestones.
• Manage vendor relationships and performance metrics, ensuring consistent delivery of high-quality data management services.
• Collaborate with Biostatistics to support data standards implementation, analysis dataset readiness, and database lock activities.
• Drive inspection and audit preparedness by maintaining compliant documentation, process traceability, and validated system oversight.
• Monitor evolving regulatory expectations related to electronic records, data integrity, and clinical research requirements and implement process improvements as needed.
• Track timelines for key study deliverables, proactively identifying risks and implementing mitigation plans to maintain project objectives.

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Informatics, or related discipline; advanced degree preferred.
• 7+ years of clinical data management experience within medical device, biotech, or pharmaceutical environments.
• Demonstrated experience leading study-level data cleaning, query management, and database lock activities.
• Prior people leadership experience, including coaching and managing direct reports.
• Strong knowledge of GCP, electronic records requirements, clinical data standards, and clinical trial data governance.
• Experience insourcing data management activities from external partners or CROs is highly desirable.
• Proficiency with leading EDC systems such as Medidata Rave, Oracle InForm, REDCap, or comparable platforms.
• Excellent communication, project management, and cross-functional collaboration skills.
• Experience supporting regulatory submissions, inspections, audits, and submission-ready datasets is preferred.
  
  

This opportunity is ideal for a hands-on data management leader who enjoys building processes, developing teams, and partnering across functions to drive high-quality clinical research execution in a fast-paced, growth-oriented environment.