Clinical Data Reviewer – Remote

Summary:

• The Clinical Data Reviewer (CDR) is a highly specialized role that performs clinical data review, supporting significant project milestones (interim analysis, study closeout, submission etc.). The studies supported by the CDR are complex comparative safety and efficacy (phase 3) trials with large, multi-faceted data sets. The review tasks performed by this role include both point-to-point clinical data checks and interpretive analysis.
• This requires that the CDR be knowledgeable about the therapeutic area under investigation, expected effects of the investigational drug and concomitant medications, and possess sufficient clinical knowledge to assess if patient data is scientifically and clinically valid.

Responsibilities:

• Independently review large scale data listings from a clinical/medical perspective
• Post queries in EDC system and follow all queries to resolution
• Clinical / medical review of subject data; reconciliation of data between multiple sources

Organizational Relationships:

• Liase with Clinical
• Liase with Data management
• The position will report to the Data Review Team Lead

Qualifications:

• Graduate degree preferred but will consider undergraduate degree with significant experience
• Minimum 5+ years clinical scientist / clinician / monitoring experience required
• Prior CRA or Prompt (Remote) Monitor experience preferred, but not mandatory if strong in data review or other skills and demonstration of quick learner
• Strong clinical research background – Ability to think critically and consider the data comprehensively
• 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))
• 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 field/CRFs interact and how data collection impacts analysis
• Strong attention to detail
• Ability to work independently and as part of team
• Ability to prioritize and adjust work priorities quickly as needed to meet deadlines (i.e., fluid, flexible work style)
• Access to internal CITRIX platform (Jreview) will be required to obtain data review listings
• Review tracking required (Excel format)
• Other internal Pfizer systems will be used a document repositories
• A thorough understanding of the processes associated with reviewing and delivering quality data.
• Strong field monitoring experience preferred
• 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
• Direct clinical data review, query writing and resolution experience an asset
• Strong background in Oncology is desirable

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.