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 subjects to find inconsistencies in 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, and constantly seeking further improvements in the quality and efficiency of clinical procedures.
Qualifications
Bachelor’s degree in one of the disciplines related to life sciences, drug development or business.
An advanced degree is desirable.
At least 5 years of clinical experience in the pharmaceutical industry.
A thorough understanding of the processes associated with reviewing and delivering quality data.
Strong field monitoring experience as 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 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 EDC experience is a must or a 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 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 (i.e., fluid, flexible work style)
Access to the internal CITRIX platform (JReview) will be required to obtain data review listings
