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Job Details

Clinical Data Reviewer - Sandwich

Company: CK Clinical
Location: Sandwich
Reference: KA41786
Closing Date: 10 May 18
Type: Contract
Salary (£): Negotiable

Job Summary:

CK Group is recruiting for a Clinical Data Reviewer to join a company in the Pharmaceutical company industry at their site based in Sandwich, Kent...


CK Group is recruiting for a Clinical Data Reviewer to join a company in the Pharmaceutical company industry at their site based in Sandwich, Kent on a 12 month contract.

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, 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 can be flexibly deployed to support multiple assets in different therapeutic areas, as needed. They  will follow relevant SOPs and regulations and understand and comply with applicable training requirements, constantly seeking further improvements in quality and efficiency of clinical procedures. They will work in conjunction with the study teams to determine what data will need to be reviewed. The CDR may train and mentor others in new data review techniques and technologies.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
•Bachelor's degree or equivalent in one of the disciplines related to life sciences, drug development or business.
Advanced degree is desirable.
•Profound clinical experience in pharmaceutical industry.
•Profound understanding of the processes associated with reviewing and delivering quality data.
•Strong field monitoring experience is an asset
•Profound 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 being 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.
•In addition to the required technical knowledge and experience, a CDR must possess a willingness to perform primarily data review tasks.
•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
•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

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA41786 in all correspondence.

Apply for this job: Clinical Data Reviewer - Sandwich

Contact Information:

Address:  Head Office
9 High Street
Tel:  +44 (0)1438 743047
Fax:  +44 (0) 1438723800
Website:  Visit Our Web Site

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