Data Manager

  • Location:

    Glasgow, Scotland

  • Sector:

    Data Science, Insight & Analytics

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Robyn Clendinning

  • Contact email:

    robyn.clendinning@search.co.uk

  • Job ref:

    RC-Data Manager_1533825516

  • Published:

    8 days ago

  • Expiry date:

    2018-09-08

  • Startdate:

    ASAP

Are you looking for a change?

Our client is a rapidly expanding medical devise manufacturer who is looking for a new Data manager to join the team.

The role

Provide data management services to support the clinical study teams based in both Glasgow and Sunrise (Fort Lauderdale)

Key duties

  • Clinical data management support
  • Reviews of clinical research documents
  • Develop data management plans
  • Develop case report forms
  • Lead the process of determining EDC database specification
  • Responsible for implementing EDC build or managing 3rd party vendors build of EDC system
  • Develops Data Transfer Agreement(s)
  • Develop test scripts and execution logs for User Acceptance Testing (UAT) of EDC systems.
  • Maintenance/tracking of EDC user management and other Clinical databases across allocated Clinical trial.
  • Perform training on study trial for EDC and create user guides.
  • Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation and/or coding.
  • Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
  • Coordinate the archiving of study databases and related documents.
  • Perform close-out audit, as specified, for closing of study trial in EDC
  • Assist in reconciling AE/SAE data including performing MedDRA coding.
  • Prepare data for presentations (internal and external)
  • Ensures data system compliance by following the established guidelines of national and international regulatory authorities.

The Person

Essential:

  • Bachelors degree in a science or mathematical related fields
  • Minimum 2 years data management experience within the scientific industry
  • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Working knowledge of Clinical database applications such as EDC and CTMS.

Desirable:

  • Experience of AE Coding

Rewards

Up to £40,000 depending on experience

Basic benefits package

Monday to Friday (1.30pm finish on a Friday.)

Search is an equal opportunities recruiter and we welcome applications from all suitably skilled or qualified applicants, regardless of their race, sex, disability, religion/beliefs, sexual orientation or age.