Clinical Data Reviewer (Canada or US) Oncology
About The Position
The Clinical Reviewer is a specialized role that performs clinical review, typically ahead of significant project milestones such as interim analysis, study closeout, and submission. Supported studies are often comparative safety and efficacy Phase 3 trials with large, multifaceted data sets. The reviewer conducts point-to-point clinical checks and interpretive analyses, including reviewing data for submission, identifying errors, and raising queries from a clinical perspective. Working as an extension of the clinician or clinical scientist, the reviewer is responsible for clinical review across one or more studies and may move between projects as needed. The role requires knowledge of the therapeutic area, expected effects of the investigational drug and concomitant medications, and sufficient clinical expertise to assess whether data is scientifically and clinically valid. Candidates must reside in the United States or Canada and must not require sponsorship. Oncology experience as a Senior CRA or CTM is required. The role may involve working independently in a virtual setting and as part of a remote team.
Requirements
- At least 7 years of clinical research experience in the pharmaceutical industry.
- Direct clinical review and query-writing and resolution experience.
- Sufficient clinical knowledge to assess whether participant data is scientifically and clinically valid.
- Proficiency reviewing large-scale listings in Microsoft Excel, including filtering, sorting, and formatting dates.
- Basic understanding of how data points from different fields and CRFs interact and how data collection affects analysis.
- Ability to work independently in a virtual setting and as part of a remote team.
- Ability to prioritize and adjust work quickly to meet deadlines, with a fluid and flexible work style.
- Basic knowledge of data management, including case report form design, electronic edit checks, data-handling conventions, and interpretation of data status reports.
- Good written and oral communication skills and strong attention to detail.
- Must reside in the United States or Canada and not require sponsorship.
- Oncology experience as a Senior CRA or CTM is required.
Nice To Haves
- Bachelor’s degree or nursing degree preferred.
- Strong monitoring experience is a plus.
- Prior EDC experience preferred.
Responsibilities
- Ensure data readiness for important milestones, including interim and final analyses, submission snapshots, Data Monitoring Committee reviews, and publications.
- Review participant-level study data in accordance with CRF Completion Guidelines (CCGs) and the Data Review Plan (DRP).
- Conduct point-to-point data checks and interpretive analyses to identify inconsistencies in participant data.
- Generate queries for discrepant data, follow them through resolution, and escalate issues that cannot be resolved through the query process.
- Create and use data-review best practices and tools to identify trends and potential safety signals.
- Identify protocol deviations during routine clinical review when applicable and escalate them appropriately.
- Follow relevant SOPs and regulations, comply with applicable training requirements, and seek improvements in the quality and efficiency of clinical procedures.
- Liaise as needed with data management, clinical and site management, and other study-team members.
- Attend clinical meetings and study meetings as necessary.
Benefits
- Medical, dental, and vision health benefits.
- Company match 401(k).
- Eligibility to participate in the Employee Stock Purchase Plan.
- Eligibility to earn commissions or a bonus based on company and individual performance.
- Flexible paid time off (PTO) and sick time; paid sick-time eligibility may vary by work location.
- Company car or car allowance may be included.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
