Clinical Data Reviewer – Oncology
Syneos Health
full-time
Posted on:
Location Type: Remote
Location: Florida • New York • United States
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Tech Stack
About the role
- 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)
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data reviewdata analysisdata managementcase report form designdata handling conventionsregulatory submissionsOncologydata review best practicesinterpretive analysispoint-to-point data checks
Soft Skills
attention to detailability to work independentlyteam collaborationflexibilityprioritizationcommunicationproblem-solvingquality improvementtime managementadaptability