Clinical Data Reviewer - Oncology Required (US, CAN, UK Only)
Syneos Health/ inVentiv Health Commercial LLC
Job Responsibilities Industry experience with oncology is required. Candidates must reside in the United States, United Kingdom, or Canada with no sponsorship needs. The Clinical Reviewer (CR) performs clinical review activities ahead of key project milestones (e.g., interim analysis, study closeout, submission). The role typically supports comparative safety and efficacy (Phase 3) trials with large, multi‑faceted data sets. Responsibilities include: Ensuring data readiness for interim analysis, final analysis, snapshots for submissions, Data Monitoring Committee reviews, and publications. Reviewing participant‑level data across a study in adherence with CRF Completion Guidelines (CCGs) and the Data Review Plan (DRP). Conducting point‑to‑point data checks and interpretive analysis, such as verifying lab tests that satisfy inclusion criteria and identifying inconsistencies in participant data. Generating queries on discrepant data and following to resolution, including escalation of issues that cannot be resolved through the query process. Using data review best practices and tools to identify trends and potential safety signals. Identifying protocol deviations during routine review and escalating as appropriate. Following relevant SOPs and regulations, maintaining training requirements, and continually improving quality and efficiency of clinical procedures. Liaising with data management, clinical, and site management teams as needed. Attending clinical meetings and study management meetings. Qualifications Bachelor's degree or nursing degree (preferred). At least 7 years of clinical research experience in the pharmaceutical industry; strong monitoring experience is a plus. Direct clinical review and query writing/resolution experience required. Ability to assess participant data for scientific and clinical validity. Prior EDC experience preferred. Proficiency in reviewing large listings in Microsoft Excel (filtering, sorting, date formatting). Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis. Capability to work independently in a virtual setting and as part of a remote team. Strong prioritization and flexibility to meet deadlines. Basic knowledge of data management, including case report form design, electronic edit checks, data handling conventions, and interpretation of data status reports. Excellent written and oral communication skills with strong attention to detail for meetings as needed. Benefits Overview Benefits may include health coverage (medical, dental, vision), retirement contributions, performance‑based bonuses, paid time off, and compliance with applicable federal, state, and municipal paid sick time requirements. Syneos Health is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate, and upholding the EU Equality Directive in all recruiting and employment activities. #J-18808-Ljbffr Syneos Health/ inVentiv Health Commercial LLC
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