Clinical Data Manager - London, United Kingdom - Cpl Life Sciences

Cpl Life Sciences
Cpl Life Sciences
Verified Company
London, United Kingdom

1 week ago

Tom O´Connor

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Tom O´Connor

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Description
Clinical Data Manager

Clinical Data Manager required for a global pharmaceutical firm based in London


A global pharmaceutical company is seeking a highly skilled Clinical Data Manager that will ensure studies are planned and implemented, that the data collected is accurate and follows compliance and regulatory guidelines.


In terms of responsibilities:

  • Assist in defining and/or create data listings, summary table validation, data specifications and/or data transfers in preparation for statistical review and/or data management audit
  • Oversight of staff training for all projects to which assigned with direct involvement in both training and supervision of staff assigned to training
  • To ensure that all data management operations are conducted to CYTE SOPs and contribute to the ongoing revision/improvement of these SOPs
  • Creation of project specific documentation for assigned trials, i.e., the Data Management Plan and the Data Management File
  • Input to EDC creation and edit check specifications
  • Creation and validation of Manual and SAS checks
  • Reconciliation of data from external sources (e.g., Serious Adverse Events, IVRS, Central Laboratory)
  • To perform verification and User Acceptance Testing of configured databases
  • Data cleaning activities
  • To review SAS listings/SAS tables
  • To create CRF and eCRF completion guidelines and EDC system manuals and access instructions
  • Production of information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor
  • To clearly define data processing guidelines
  • Performance of QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects
  • Liaise with sites around the world to troubleshoot data queries
  • Identify and raise data queries ensuring appropriate close out
  • Create a data review plan for the study lifecycle
  • Report risks and meet with other functions to discuss data issues
  • Perform close out audit, as specified, for closing of study trial in EDC or other clinical data management databases
  • Participate in conference calls and/or meetings with vendors
  • Input to process development and improvement

Clinical Data Manager will require:

  • Life Science Degree, Nursing qualification, or relevant industry experience
  • Essential that the job holder is able to work with close attention to detail, scrutinize the validity of the data being entered and has the ability to phrase data queries in a clear and impartial manner
  • At least two years data management or other related work experience in clinical research
  • Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
  • Ability to train new staff and to monitor their performance


This is a great opportunity for a Clinical Data Manager to work within a global pharmaceutical organisation that are innovative within their field, supporting the development of ground breaking research.


This is an opportunity to be a part of a growing organisation that has an impact on many people's lives.

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