Clinical Data Reviewer – Oncology

Role Overview

• The CDR may be responsible for the clinical data review of one or more studies with the ability to move easily from project to project as necessary
• The CDR has comprehensive knowledge and understanding of the therapeutic area under study and uses that knowledge to ensure that patient data are scientifically and clinically valid
• The studies supported by the CDR are often, but not exclusively, complex comparative safety and efficacy (phase 3) trials with large, multi-faceted data sets
• In addition the CDR ensures data readiness for important milestones including, but not limited to, interim analysis, final analysis, snapshots to support submissions, Data Monitoring Committee reviews and publications
• Review tasks performed by the CDR include both point-to-point data checks (e.g., verifying the presence of a blood pressure value that satisfies study inclusion criteria) and interpretive analysis (e.g., evaluating subject to find inconsistencies the patient’s data)
• The CDR will create and use data review best practices and associated data review tools to identify trends and any safety signals
• Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures

Requirements

• Bachelor’s degree in one of the disciplines related to life sciences, drug development or business
• At least 7 years of clinical experience in pharmaceutical industry
• A thorough understanding of the processes associated with reviewing and delivering quality data
• Strong field monitoring experience an asset
• Deep Clinical Research experience in the phase 3/pivotal space, ideally on the side of the sponsor and with a track record of successful regulatory submissions
• Strong background in Oncology
• Strong technical data review skills and comfortable with the review of large sets of clinical data under often challenging timelines
• Familiar with Oracle Clinical Remote Data Capture and/or other database systems; technically competent with Microsoft Excel and ideally, Access
• Possesses at least 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
• Prior InForm EDC experience a must or very quick learner for data platform technology systems
• Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date)
• Moderate level of tech savvy to learn new systems quickly and to be able to navigate independently in different systems
• Basic understanding of how data points from different field/CRFs interact and how data collection impacts analysis
• Strong attention to detail
• Ability to work independently and as part of team
• Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e., fluid, flexible work style)

Tech Stack

• Oracle

Benefits

• Health benefits to include Medical, Dental and Vision
• Company match 401k
• eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• flexible paid time off (PTO) and sick time