Clinical Data Reviewer – Oncology
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Job Description
Clinical Data Reviewer specializing in Oncology at Syneos Health. Ensuring data readiness and conducting clinical reviews for oncology studies.
Responsibilities:
- Ensure 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 participant level data across a study in adherence with CRF Completion guidelines (CCGs) and the Data Review Plan (DRP)
- Conduct point-to-point data checks (e.g. verifying the presence of a lab test that satisfies study inclusion criteria) and interpretive analysis (e.g. reviewing to identify inconsistencies in the participant’s data).
- Generate queries on discrepant data and follow to resolution including escalation of issues that cannot be resolved through the query process
- Create and use data review best practices and associated data review tools to identify trends and any safety signals
- May identify protocol deviations during routine clinical review and escalation as appropriate
- Follow relevant SOPs and regulations, have an excellent understanding of and comply with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures
- May liaise with data management, clinical and site management along with other members of the study team
- Attend Clinical Meetings and Study Meetings as necessary
Requirements:
- Bachelor’s degree or nursing degree is preferred
- At least 7 years of clinical research experience in the pharmaceutical industry (Strong monitoring experience is a plus)
- Direct clinical review and query writing/resolution experience required
- Possess sufficient clinical knowledge to assess if participant data is scientifically and clinically valid.
- Prior EDC experience preferred
- Proficient in reviewing large scale listings in Microsoft Excel format (filter, sort, data format (date).
- Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis
- Ability to work independently in a virtual setting and as part of a remote team
- Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e. fluid, flexible work style)
- Possess 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
- Good written and oral communication skills with strong attention to detail required meetings, as necessary
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
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