Senior Clinical Data Manager
About The Position
Odyssey is seeking a Senior Clinical Data Manager to own clinical data management deliverables from study start-up through close-out. Reporting to the Director of Clinical Data Sciences, you'll independently support active programs and studies, ensuring complete, accurate, and regulatory-compliant data that powers study reports, publications, and regulatory submissions. You'll serve as the primary data management voice on cross-functional study teams, partnering closely with clinical operations, biostatistics, statistical programming, safety and pharmacovigilance, medical monitoring, regulatory affairs, and external CRO partners to deliver high-quality, reliable clinical trial data. This is a role for someone who knows established clinical trial paradigms deeply — and is equally energized by new approaches to data aggregation and analysis that advance patient care. While hands-on study execution is at the heart of this role, you'll also have the opportunity to shape how we work: contributing to process development, vendor oversight, and inspection readiness as our clinical data sciences capabilities grow.
Requirements
- BS/MS in a relevant discipline
- 5+ years of clinical data management experience in a sponsor and/or CRO setting
- Comprehensive knowledge of drug development and clinical research processes, GCP guidelines, regulations, and standards related to clinical data management
- Strong hands-on experience with data management systems, technologies, and standards, including EDC, IRT, and data analytics platforms
- Strong problem-solving and critical thinking skills, with keen attention to detail
- Excellent verbal and written communication skills
- Self-motivated and able to work autonomously, while taking direction and collaborating effectively within a high-functioning team, with the highest standards of professionalism and ethics
Nice To Haves
- Life sciences background a plus
Responsibilities
- Responsible for relationships with data management partners (e.g., CROs and vendors)
- Oversight of outsourced study-related data management activities including CRF design, data collection, edit checks, and listing reviews, data transfer specifications/agreements with external vendors, data reconciliation (SAEs, labs, other external data), medical coding, UAT, IRT, database lock and archival of data management documents
- Accountable for ensuring data integrity, data quality and timeliness of data management deliverables
- Lead internal cross-functional data reviews and query management activities
- Monitor key data management metrics and study performance indicators
- Provide feedback on draft protocols and functional area plans and outputs as appropriate (e.g. Clinical Monitoring Plan, Risk Management Plan, Medical Monitoring Plan, Safety Management Plan, Statistical Analysis Plan (SAP), Clinical Study Reports (CSR), Tables, Listings and Figures, etc.)
- Maintain data integrity in compliance with GCP, relevant SOPs, regulatory requirements and industry best practices/standards
- Ensure documentation of all data management related activities and Trial Master File readiness
- Attends and represents data management effectively on all assigned studies and programs at relevant meetings
- Support regulatory inspections, audits, and submission activities
- Other related duties as may be determined or assigned
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What This Job Offers
Job Type
Full-time
Career Level
Senior
