Medical Data Reviewer
Core
Perform clinical data review and quality assurance for oncology clinical trials, identifying errors and ensuring data integrity for regulatory submissions.
Role type
Senior Clinical Data Reviewer (Oncology)
Builds
High-quality clinical datasets for regulatory filings (CSR, DSUR, IBs) and study close-outs.
Domain
Clinical Research / Oncology / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical crosscheck, Solid Tumor Oncology expertise, Coding review, Clinical database navigation, GCP knowledge, Clinical trial design understanding, Medical terminology, Analytical skills, Attention to detail
Preferred skills
8+ years of clinical data review experience, Project management, Query writing training, MS Excel proficiency
Technologies
Electronic Data Capture (EDC) systems, Clinical listings, Standard data formats
Responsibilities
Review patient eligibility, diagnosis, medical history, and safety data (AE/SAE); Issue and track clinical data queries; Conduct in-stream data trend analysis; Monitor site data entry performance; Prepare materials for data dissemination meetings (IDMC, SC, Investigator meetings); Support clinical narrative preparation for Clinical Study Reports (CSR).
Seniority
Senior, hands-on IC