Syneos Health is hiring a Clinical Data Reviewer to ensure the quality and readiness of clinical data for complex trials. In this remote role, you will apply your deep therapeutic and clinical research knowledge to review patient data, supporting key milestones like regulatory submissions and final analysis.
What You'll Do
- Perform clinical data review for one or more studies, moving between projects as necessary.
- Use comprehensive therapeutic area knowledge to ensure patient data are scientifically and clinically valid.
- Ensure data readiness for critical milestones including interim analysis, final analysis, snapshots for submissions, Data Monitoring Committee reviews, and publications.
- Conduct both point-to-point data checks and interpretive analysis to identify inconsistencies in patient data.
- Create and utilize data review best practices and tools to identify trends and any safety signals.
- Follow relevant SOPs and regulations, comply with training requirements, and seek improvements in quality and efficiency.
- Review large-scale listings in Microsoft Excel format, including filtering, sorting, and formatting data.
- Maintain review tracking in Excel format.
What We're Looking For
- Bachelor’s degree in a discipline related to life sciences, drug development, or business.
- A thorough understanding of the processes for reviewing and delivering quality data.
- Deep Clinical Research experience in the phase 3/pivotal space, with a track record of successful regulatory submissions.
- Strong technical data review skills and comfort reviewing large sets of clinical data under challenging timelines.
- Familiarity with Oracle Clinical Remote Data Capture and/or other database systems.
- Technical competency with Microsoft Excel and ideally, Access.
- At least basic knowledge of data management including CRF design, electronic edit checks, data handling conventions, and data status reports.
- Prior InForm EDC experience is a must or the ability to be a very quick learner for data platform technology systems.
- Proficiency in reviewing large-scale listings in Microsoft Excel format.
- Moderate level of tech savvy to learn new systems quickly and navigate independently; access to the internal CITRIX platform (JReview) will be required.
- Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis.
- Strong attention to detail.
- Ability to work independently and as part of a team.
- Ability to prioritize and adjust work priorities quickly as needed to meet deadlines.
Nice to Have
- Advanced degree is desirable.
- Strong field monitoring experience is an asset.
Technical Stack
- Oracle Clinical Remote Data Capture
- Microsoft Excel
- Microsoft Access
- InForm EDC
- CITRIX platform (JReview)
Work Mode
This is a fully remote position open to candidates based in the United Kingdom and the United States only.
Syneos Health is passionate about developing our people through career development and progression. We are committed to our Total Self culture where you can authentically be yourself, dedicated to taking care of our people, and building a place where everyone feels like they belong.
Syneos Health is an equal opportunity employer.
