Assoc. Director, Data Management
Kiniksa Pharmaceuticals · Lexington, MA
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Role summary
Kiniksa Pharmaceuticals seeks an Associate Director of Data Management to lead clinical data strategies across studies, from protocol review through database lock and regulatory submission. This Lexington, MA-based role reports to the Senior Director of Biostatistics and requires on-site presence five days weekly.
What they're looking for
- Strategic leadership experience in clinical data management across multiple studies
- Expertise in EDC systems, database specification, and eCRF design
- Knowledge of clinical trial protocols, case report forms, and regulatory requirements
- Experience overseeing CRO data management activities and cross-functional coordination
- Proficiency with data quality processes, validation, reconciliation, and coding
- Demonstrated ability to develop SOPs and clinical data management documentation
What you'll be doing
- Lead end-to-end data management from protocol review through database lock and archival
- Oversee EDC database specification, eCRF design, edit rules, and validation logic
- Manage data quality assurance, reconciliation, and coding for statistical readiness
- Coordinate user acceptance testing and ensure eDiary/PRO data collection meets objectives
- Drive study milestones, identify risks, and implement solutions across programs
Privacy & handoff
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