Syneos Health is looking for a Clinical Data Reviewer to ensure the scientific and clinical validity of patient data in complex clinical trials, contributing to data readiness for critical milestones and regulatory submissions.
Requirements
- A thorough understanding of the processes associated with reviewing and delivering quality data.
- 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 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)
Responsibilities
- 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 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.
- Reviews participant level data across a study in adherence with the Data Review Plan and coordinates with Lead Clinical Scientist for study level review as delegated.
Other
- Remote Role: Open to UK and all of US - No sponsorship is available.
- Bachelor’s degree in one of the disciplines related to life sciences, drug development or business. Advanced degree is desirable.
- Strong field monitoring experience an asset
- Moderate level of tech savvy to learn new systems quickly and to be able to navigate independently in different systems
- Strong attention to detail
