Description
Syneos Health is seeking a Clinical Data Reviewer (CR) to join their Clinical Solutions team. The CR will perform clinical reviews of studies, typically ahead of significant project milestones, and will be responsible for ensuring data readiness for important milestones.
Job Responsibilities
- Ensure data readiness for important milestones, including interim analysis, final analysis, and submissions
- Review participant-level data across a study in adherence with CRF Completion guidelines and the Data Review Plan
- Conduct point-to-point data checks and interpretive analysis to identify inconsistencies in participant 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 safety signals
- May identify protocol deviations during routine clinical review and escalate as appropriate
- Follow relevant SOPs and regulations, and seek further improvements in quality and efficiency of clinical procedures
- Liaise with data management, clinical and site management, and other members of the study team
Qualifications
- Bachelor's degree or nursing degree preferred
- At least 7 years of clinical research experience in the pharmaceutical industry, with strong monitoring experience a plus
- Direct clinical review and query writing/resolution experience required
- 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
- 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
- Possess basic knowledge of data management, including case report form design and electronic edit checks
- Good written and oral communication skills with strong attention to detail required
Benefits
- Company car or car allowance
- Health benefits, including 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