Senior Manager, Clinical Data Management

Role Summary

The Senior Manager, Clinical Data Management leads end-to-end clinical data management across assigned studies/programs, establishing best-in-class standards and processes, optimizing systems, and overseeing CRO/vendor execution. Partners with Biostatistics, Clinical Operations, Safety, and Regulatory to deliver timely, compliant, inspection-ready, high-quality data that enable analyses, submissions, and data-driven decisions; and drives continuous improvement.

Responsibilities

• Represent the Moderna Data Management function for clinical studies within the assigned therapeutic area/program; align expectations between external data vendors and Moderna cross-functional stakeholders for all data-related deliverables.
• Ensure achievement of Data Management milestones in coordination with Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance.
• Develop/execute or oversee eCRF UAT plans and test scripts; perform thorough pre-deployment testing.
• Lead the design, creation, testing, and implementation of data-capture tools and integrations for capture, processing, coding, and validation, per protocol requirements and industry best practices.
• Author or oversee core Data Management documentation, including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.
• Lead cross-functional data review for the program/therapeutic area; equip teams with the tools and processes required for effective review.
• Manage clinical trial data‚Äîreview, cleaning, audit, and validation‚Äîto ensure regulatory-compliant handling; review analysis listings, report on performance and quality, and monitor trends within and across studies.
• Collaborate with the Data Standards Committee as a liaison among study team members to standardize data collection and reporting.
• Ensure archival and inspection-readiness of all Data Management TMF documents.

Qualifications

• Bachelor‚Äôs degree in an analytical or health-related field.
• 6+ years of clinical data management experience in industry, with experience across indications and relational databases and experience using multiple clinical data management systems.
• Thorough command of FDA and ICH GCP guidelines and industry standards applicable to data capture and data management process to ensure the appropriate conduct of clinical studies.
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
• Outstanding verbal and written communication skills, in addition to excellent organizational skills.
• An ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
• Creative, capable problem-solver.

Skills

• Data management systems; eCRF/UAT; data capture and integration; data quality monitoring; cross-functional collaboration; documentation and specifications drafting; TMF archival readiness.

Education

• Bachelor‚Äôs degree in an analytical or health-related field.