Clinical Data Reviewer (Oncology)

Accountabilities:

• Ensure clinical data is ready for critical study milestones, including interim and final analyses, regulatory submission snapshots, Data Monitoring Committee reviews, and publications.
• Conduct participant-level clinical data reviews in accordance with CRF Completion Guidelines (CCGs), Data Review Plans (DRPs), relevant SOPs, and applicable regulations.
• Perform point-to-point data checks, such as verifying whether laboratory results and other clinical information meet study inclusion or protocol requirements.
• Conduct interpretive clinical reviews to identify inconsistencies, unexpected findings, data trends, and potential safety signals across large datasets.
• Generate queries for discrepant or clinically questionable data and follow them through to resolution, escalating unresolved issues when appropriate.
• Develop and apply data review best practices and associated review tools to improve the identification of trends, inconsistencies, and clinically relevant findings.
• Identify potential protocol deviations during routine clinical review and escalate them according to applicable procedures.
• Collaborate with data management, clinical teams, site management, and other study stakeholders to resolve data issues and maintain study quality.
• Participate in clinical meetings and study-related activities, contributing clinical data expertise and supporting effective study execution.
• Continuously identify opportunities to improve the quality, consistency, and efficiency of clinical review procedures.

Requirements

• At least 7 years of clinical research experience within the pharmaceutical industry, with strong clinical monitoring experience considered an advantage.
• Previous CRA or CTM experience in oncology is required, along with direct experience conducting clinical data reviews and writing and resolving queries.
• Strong clinical knowledge of oncology and the ability to determine whether participant data is scientifically and clinically valid.
• Bachelor’s degree or nursing degree preferred, or equivalent relevant clinical research experience.
• Prior experience with Electronic Data Capture (EDC) systems is preferred.
• Strong Microsoft Excel skills, particularly when working with large-scale clinical listings, including filtering, sorting, and formatting dates and other data.
• Basic understanding of how data points across different fields and CRFs interact and how data collection decisions can affect downstream analysis.
• Working knowledge of clinical data management concepts, including CRF design, electronic edit checks, data-handling conventions, and interpretation of data status reports.
• Strong attention to detail and analytical skills, with the ability to identify discrepancies and assess complex clinical information.
• Excellent written and verbal communication skills, with the ability to clearly communicate findings and collaborate effectively with cross-functional teams.
• Ability to work independently in a fully remote environment while contributing effectively to a distributed team.
• Flexible and adaptable working style, with the ability to reprioritize quickly and manage competing deadlines in a changing project environment.
• Must reside in Canada and be able to work without sponsorship.

Benefits

• Fully remote working environment for candidates based in Canada.
• Full-time opportunity supporting significant oncology clinical research programs.
• Exposure to complex, large-scale clinical datasets and important study milestones, including analyses, submissions, and publications.
• Opportunity to collaborate with experienced professionals across clinical research, data management, site management, and related functions.
• Access to therapeutic-area and technical training designed to support continued professional development.
• Career development and progression opportunities supported by engaged line management and coaching.
• Peer recognition and total rewards programs.
• Opportunities to expand your expertise through specialized clinical and functional teams.
• Exposure to emerging technologies, data, scientific knowledge, and innovative approaches to clinical development.
• Collaborative environment where diverse perspectives, knowledge sharing, and cross-functional problem solving are encouraged.
• Opportunity to contribute to clinical programs that can help accelerate the development and delivery of important therapies to patients worldwide.
• Compensation and additional benefits are determined by the hiring company and will be discussed during the recruitment process.