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Clinical Data Reviewer - Home Working Available

Employer
Pfizer
Location
England
Salary
Negotiable
Closing date
4 Mar 2020

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Sector
Science & Pharmaceuticals
Hours
Full Time
Flexibility
Home working available
Contract Type
Permanent

Job Details


ROLE SUMMARY

The Clinical Data Reviewer (CDR) is a highly specialized role that performs clinical data review, typically ahead of significant project milestones (interim analysis, study closeout, submission etc.). 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. 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.

CDRs are part of the Clinical Sciences function and may be flexibly deployed to support multiple studies in different therapeutic areas, as needed.

They will work independently in close partnership with the Clinical Scientist; Clinical Data Scientists along with other members of the study team to ensure clinical data review deliverables as described in the data review plan are met on time and with high quality.

The CDR may assist with the training and/or mentoring of other CDRs in new data review techniques and technologies.

ROLE 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 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 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.
  • May participate in portfolio and enterprise level workgroups aimed at optimizing PFE clinical development procedures.

QUALIFICATIONS

  • Bachelor's degree in one of the disciplines related to life sciences, drug development or business.
    Advanced degree is desirable.
  • Clinical experience in pharmaceutical industry.
  • A thorough understanding of the processes associated with reviewing and delivering quality data.
  • Strong field monitoring experience 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 background in Oncology
  • 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.
  • Leverages knowledge from others related to overall objectives, strategy, critical issues and policy matters
  • Promotes team health and exemplifies Pfizer's OWN-IT principles
  • Has foresight and judgment in complex decisions
  • Leverages a variety of communication tools and techniques to communicate results
  • Promotes innovation and takes appropriate risks to challenge the status quo, resulting in enhanced processes
  • Ability to work proactively and independently, organize tasks, time and priorities of self and others; ability to multi-task
  • Collaborative problem solving (handles conflict constructively)
  • Able to embody leadership behaviors and competencies

Company

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. 

In the UK, we have around 2,400 colleagues across four locations, working within our commercial business, research and development (R&D), manufacturing and distribution operations.

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