Telephone 0203 778 0909 | Email office@al2s3.com

Senior Clinical Data Manager

  • Location:
  • Salary:
    £45,000 - £50,000
  • Job type:
    Permanent
  • Posted:
    1 month ago
  • Category:
    Clinical
  • Deadline:
    March 20, 2020

                                             

AL Solutions are working with a small and expanding UK based CRO. We are looking for a Senior Clinical Data Manager to work remotely and to take the lead on studies from a data management and project management perspective.

Responsibilities – Senior Clinical Data Manager

  • Performing the Lead Data Manager role with responsibility for the successful quality, planning, execution, monitoring, control and finalisation of all data management activities with effective management of timelines, budget and quality.
  • Planning: Definition and maintenance of Data Management project plan, input into the overall project plan. Responsible for the execution of all data management aspects of the project plan and reporting of status across the project team.
  • Resourcing: Definition of Data Management resource needs for the life time of the study including the identification and communication of short term resource fluctuations. Flexible and efficient use of assigned resource.
  • Documentation: Implementation and maintenance of accurate, clear Data Management documentation. Responsible for the setup, maintenance and finalisation of the Data Management Study File
  • Study Team Management: Oversight of all data review activities; measuring progress against the project plan.
  • Contract and Budget: Detailed knowledge and understanding of contracted Data Management obligations and associated budget; Ongoing assessment of budget, regular and accurate review of Data Management progress against financial milestones and monthly completion metrics.
  • Client Management: Leads and drives all Data Management communication and acts as the primary client contact for Data Management activities
  • Risk management and Escalation: Identifies, manages and communicates risk to timelines, quality and budget.
  • Contributes to the ongoing development of the Data Management department through process analysis and improvement, mentoring, system enhancement.
  • Liaises successfully with colleagues across the company to achieve a cohesive and co-ordinated service to our clients and the development of a strong spirit. Supports business development activities.
  • To effectively support regulatory and sponsor audits

Experience – Senior Clinical Data Manager

  • Data Management experience within a Pharmaceutical company or CRO
  • Strong experience across all phases of clinical development
  • Expert CDISC knowledge
  • Experience leading studies across phases (I-III)
  • Experience liaising with external vendors and sponsors
  • Experience handling timelines, deliverables, and budgets for projects

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