Clinical Data Reviewer (Manager)

The Clinical Data Reviewer (CDR) is highly specialized to perform clinical data review, most often in a submission timeline. The studies supported by the CDR are often, but not exclusively, complex comparative safety and efficacy (phase 3) trials that are high-enrolling and require robust data capture. This role is distinctly different from that of the Data Manager in that review tasks include both point-to-point data checks and interpretive analysis. In particular, the interpretive review portion of a CDR's responsibilities requires that the CDR be knowledgeable about the therapeutic area under investigation, expected effects of the investigational drug and supportive medications, and possess sufficient clinical knowledge to assess if patient data is logical. CDRs are part of the Clinical function and will be flexibly deployed to support multiple assets in different therapeutic areas, as needed. They will work independently in conjunction with the Clinical Scientist, Clinical Data Scientists along with other members of the study team to determine what data will need to be reviewed. In addition, the CDR will work in a matrixed environment, is responsible for training and mentoring others in new data review techniques and technologies and will be responsible for determining the resourcing for the projects being reviewed