Senior Clinical Data Manager, Clinical Data Science

Senior Clinical Data Manager — Clinical Data Science

Summary
The Senior Clinical Data Manager is responsible for all aspects of clinical data management throughout study conduct, executing policies/procedures to gather, analyze, and report clinical data for trials in compliance with Good Clinical Practice (GCP) and regulatory requirements.

Responsibilities
- Act as lead data manager within study team
- Perform/oversee database development and management (CRF Specifications, Edit Check Specifications, Programming Specifications & QC, User Acceptance Testing, open/clean/lock)
- Support adoption of Clinical Data Warehouse technology for streamlined review
- Implement Risk Management Planning
- Author/review/approve study documents (e.g., Data Management Plans, Data Transfer Agreements, CRF Completion Guidelines, Manual Review Guidelines)
- Manage ongoing CDM activities: CRF review, query generation, receipt/reconciliation of external data, SAE reconciliation, data listings, and CDM summary reports within timelines
- Perform medical coding using MedDRA & WHODrug
- Ensure CDM compliance with regulatory authority requirements and GCP
- Evaluate issues and implement mitigation solutions; assist/lead vendor selection
- Oversee external service providers/contractors/direct reports for data management and EDC; participate in ESP governance
- Support regulatory inspection activities; liaise with document specialists
- Present at investigator meetings and trainings; represent CDM at study meetings and facilitate cross-functional activities
- Provide updates on timelines/vendor oversight; proactively address data questions; implement best practices/process improvements
- Travel: 10–20% domestic/international (variable)

Competencies
- Analytical/problem-solving; organizational/time management; communication; stakeholder relationship management
- Attention to detail; flexibility; strong work ethic

Requirements
- Bachelor’s degree (BA/BS) preferred
- 5+ years Clinical Data Management; 2+ years as Study Lead Data Manager
- EDC systems experience
- CDISC CDASH and SDTM working knowledge
- Training/experience: GxP (ICH, Good Quality Practices), 21 CFR Part 11 & computer security, HIPAA, drug development/approval process, data management overview
- MS Office (Word, Excel, PowerPoint) proficiency
- Medical coding experience preferred (MedDRA/WHODrug)

Application
Apply at http://www.ionis.com; reference requisition #IONIS003961.

Benefits/Pay
- Pay scale: $95,000 to $151,418
- Mentions an “excellent benefits package” with full benefits link: https://www.ionis.com/careers/working-at-ionis/