Clinical Data Reviewer (Oncology)

Job description

**This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Data Reviewer (Oncology) based in Canada.** As a Clinical Data Reviewer, you will play a critical role in ensuring clinical trial data is accurate, complete, scientifically valid, and ready for key study milestones. You will support complex oncology studies, often involving large and multifaceted datasets across different stages of clinical development. The role combines detailed participant-level data review with interpretive analysis to identify inconsistencies, potential safety signals, and issues requiring resolution. You will work closely with clinical, data management, site management, and broader study teams in a highly collaborative virtual environment. Your expertise will help support interim and final analyses, regulatory submissions, Data Monitoring Committee reviews, and publications. This is an opportunity to apply deep clinical research knowledge while contributing directly to the quality and efficiency of clinical development programs. ### 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.