Data Manager

Recruiter
Hays Resource Management - Astrazeneca
Location
Cambridge
Salary
Competitive
Posted
01 Dec 2016
Closes
08 Dec 2016
Contract Type
Contract
Hours
Full Time

Data Manager Contractor -12 months

We are recruiting for a Contract Data Manager Lead to cover the secondment of a Data manager Expert (DME) in Early Clinical Development for a 12 month contract. The Role will require travel to Cambridge 1 day per month otherwise you will be required to work from home. As the Data Manager you will provide support and guidance within Data Management processes and related activties for ECD within defined vendor models. The ideal candidate will provide expertise on data management to projects teams and vendors, input into AZ standards and ensure quality deliverables from vendors. Previous Oncology experience is required.

Experience required:

Experienced background in operational Data management with at least 6 years' experience:

  • Led multiple studies at the same time or a large phase III study
  • Data review/data validation tasks
  • Development of Data Management documentation
  • Experience of reviewing clinical research documentation
  • Electronic Data Capture experience
  • Experience in Early clinical Studies, Phase 1 and 2 in Oncology and or respiratory/Cardiovascular TA standards (CDASH and SDTM)
  • Experience in Early Clinical (phase I and II) studies
  • Oncology experience
  • Cardiovascular experience
  • Respiratory experience
  • Standards experience
  • SDTM knowledge

Excellent communication/project management skills, with experience in the following:

  • Working cross-functionally
  • Communicating with different stakeholders within a project
  • Communicating with external stakeholders
  • Leading a project/work stream

Experience of leading DM activities within outsourcing models

  • Experience and understanding of sponsor/CRO collaboration
  • Awareness of different data management terminology and processes

Excellent knowledge of GCP, GMP and Clinical research

  • Excellent knowledge of GCP
  • Knowledge of GMP
  • Excellent knowledge of the clinical development process
  • Knowledge of regulatory requirements and terminology

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