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

JOB RESPONSIBILITIES

• The CDR is routinely responsible for the clinical data review of one or more studies/programs, most often within a submission timeline and has the ability to simultaneously move easily from project to project.
• 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. 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 subject to find inconsistencies the patient’s data).
• The CDR will use data review best practices and associated data review tools to identify trends and any safety signals.
• The CDR routinely provides functional management of studies and or compounds being reviewed.
• The CDR will perform and coordinate the data review deliverables across studies and at the program level.
• The CDR will determine how each project will be resourced, reviewed by using ascertaining available resources and expertise of other CDRs.
• The CDR is responsible for training and mentoring other CDRs.
• 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.
• Regularly supports in portfolio and enterprise level workgroups aimed at optimizing PFE clinical development procedures.
• Provides data review subject matter expertise support for studies, as needed, within Clinical Sciences group.

QUALIFICATIONS:

Education

BS or MS required. Advanced degree is desirable.

Experience

• At least 7 years of clinical experience in pharmaceutical industry.
• Extensive understanding of the processes associated with reviewing and delivering quality data.
• Strong field monitoring experience an asset
• Extensive 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.

PHYSICAL/MENTAL REQUIREMENTS

• Able to work on the computer, communicate efficiently via phone and/or WebEx.
• Mentally able to fulfill the responsibilities of the role.
• Must have the relevant personality features supporting the responsibilities:
• In addition to the required technical knowledge and experience, a CDR must possess a willingness to perform primarily data review tasks.
• Able to work independently for periods of several days with minimal supervisory contact.
• Willing to work in a virtual team setting where there is very little in-person contact.