Sr Clin Data Mgmt Assoc
Core
Oversee clinical data management for CAR T-cell therapy studies from start-up to close-out, ensuring data quality and compliance for oncology clinical development programs.
Role type
Senior IC clinical data management associate (oncology/cell therapy)
Builds
Clinical development programs for personalized CAR T-cell therapies
Domain
Biopharmaceuticals / Oncology / Cell Therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management, eCRF design, protocol review, data quality assurance, query management, regulatory compliance (FDA/EMA/ICH), vendor coordination, timeline management, data transfer planning
Preferred skills
Oncology experience, hematological cancers knowledge, cell therapy background, lab data handling, MedDRA/WHODD familiarity, regulatory submission experience
Technologies
Medidata Rave, clinical data management systems
Responsibilities
Lead studies/projects without supervision, ensure completeness/accuracy/consistency of clinical data, prepare and design eCRFs, interact with site coordinators/investigators to resolve queries, manage external vendor data deliverables, coordinate database snapshots for analysis, ensure adherence to standard business processes
Seniority
Senior, hands-on IC
