Clinical Data Reviewer - Oncology

Clinical Data Reviewer – Oncology (US, Canada only)

The Clinical Reviewer (CR) is a specialized role that performs clinical review, typically ahead of significant project milestones such as interim analysis, study closeout, and submission. The CR supports Phase 3 trials with large, multi‑faceted data sets and is responsible for the clinical review of one or more studies, moving easily from project to project as necessary.

Industry experience with Oncology is required. Candidates must reside in the United States or Canada; no sponsorship is needed.

• Ensure data readiness for important milestones, including interim analysis, final analysis, snapshots for submissions, Data Monitoring Committee reviews, and publications.
• Review participant‑level data across a study in adherence with CRF Completion guidelines (CCGs) and the Data Review Plan (DRP).
• Conduct point‑to‑point data checks (e.g., verifying the presence of a lab test that satisfies study inclusion criteria) and interpretive analysis (e.g., identifying inconsistencies in participant data).
• Generate queries on discrepant data and follow through to resolution, including escalation of issues that cannot be resolved through the query process.
• Create and use data review best practices and associated tools to identify trends and any safety signals.
• May identify protocol deviations during routine clinical review and escalates as appropriate.
• Follow relevant SOPs and regulations, maintain an excellent understanding of applicable training requirements, and constantly seek further improvements in quality and efficiency of clinical procedures.
• May liaise with data management, clinical, and site management along with other members of the study team.
• Attend Clinical Meetings and Study Me

• Bachelor's degree or nursing degree is preferred.
• At least 7 years of clinical research experience in the pharmaceutical industry (strong monitoring experience is a plus).
• 3+ years of oncology experience.
• Direct clinical review and query writing/resolution experience required.
• Possess sufficient clinical knowledge to assess if participant data is scientifically and clinically valid.
• Prior EDC experience preferred.
• Proficient in reviewing large scale listings in Microsoft Excel (filter, sort, data format).
• Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis.
• Ability to work independently in a virtual setting and as part of a remote team.
• Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (fluid, flexible work style).
• Possess basic knowledge of data management, including case report form design, workings of electronic edit checks, implementation of data handling conventions, and interpretation of data status reports.
• Good written and oral communication skills with strong attention to detail required for meetings, as necessary.

Benefits for this position may include a company car or car allowance, health benefits (medical, dental, vision), company match 401(k), eligibility to participate in an Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Salary range: $80,600.00 - $.

Equally qualified and independent applicants are encouraged to apply. We consider all qualified employees and applicants for admission without regard to race, color, origin, religion, marital status, sex, gender, gender identity, age, or disability. The Company commits to compliance with the Americans with Disabilities Act, including reasonable accommodations to assist employees or applicants in performing essential job functions. The Company’s employment practices comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive.