OPR Associates

Senior Data Manager

4 days left

Norfolk (GB)
£50,000 per annum
01 Feb 2021
03 Mar 2021
Full Time
Contract Type
Experience Level

We are currently seeking a Senior Data Manager with CRO, SAS, study leadership and team leadership experience to join our Client based in the East Anglia area. This is a full time, permanent position with the potential for remote working.

The Company

Our client is one of the largest specialist data focused contract research companies in Europe supporting human clinical trials developing new life saving drugs. Using its innovative Electronic Data Collection system, ePRO mobile app and related biometrics services, the company is a market leader in the healthcare arena.

The role will involve:

  • Lead the development and finalisation of high-quality data management documentation e.g., Data Management Plan, Data Validation Plan, Data Transfer Specifications, CRF Completion Guidelines
  • Define, communicate and lead the execution of the data management project plan.
  • As Lead Data Manager, perform, lead and coordinate all data review and query management activities per study documentation and the project plan to produce high quality clinical data deliverables.
  • Through oversight and effective delegation, ensure data management activities on assigned studies are completed according within the scope of the study contract and manage progress against the study contract and project plan; Maintain accurate resource forecasts.
  • Perform SAE reconciliation and associated updates within agreed timelines, check for and follow up potentially unreported Serious Adverse Events (SAEs) on the clinical database.
  • Maintain accurate, up to date data management documentation.
  • Define and maintain data tracking and status information to enable accurate assessment and reporting of study status internally and with the sponsor.
  • Maintain and takes responsibility for the execution of data management activities per the project plan.
  • Prepare and participate in client and in-house audits and regulatory inspections.
  • Develop and maintain advanced knowledge and understanding of all relevant systems and processes.
  • Mentor and support the development and progression of Data Associate IIs and Data Managers
  • Lead and contribute to the development, maintenance and delivery of data management training as and when required.
  • Lead and contributes to the ongoing development and process improvement of the department and across the company; Act as a Subject Matter Expert if required.

The ideal Candidate will have:

  • Financial reporting
  • eCRF knowledge
  • Strong SAS knowledge
  • Contract research organisation industry experience
  • 3-4 years Data management experience
  • Team leadership or Mentorship experience
  • Study leadership experience

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