Senior Clinical Data Manager

United Kingdom
Up to £50,000
05 Jul 2019
04 Aug 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)

AL Solutions are searching for a Senior Data Manager to work for a mid-sized international CRO at the heart of expansion. This opportunity is for UK based citizens and can be worked from home.

Our client has been established for over 20 years and run/manage clinical trials in over 50 countries across a variety of therapy areas with their majority expertise in Rare Disease and Oncology. Therefore, you have the ability to work on small and innovative rare disease studies as well as more complex and international oncology studies.

The Data Management department is expanding, hence the need for a new Manager to run a small DM/programming team.

Senior Data Manager Responsibilities

  • Coordinating and reviewing clinical data, analysing tables, figures and patient profiles for data consistency and accuracy
  • Reviewing and resolving data discrepancies
  • Projection and management of Data Management study timelines
  • Tracking and Monitoring of KPIs and billable hours against budgeted hours
  • Complete project trend analysis
  • Create CAPA and root cause analysis for assigned studies and ensure audit readiness
  • Filing documents in the TMF, updating study trackers and reports
  • Completion of quality of study start-up documents
  • Work with the Clinical Database Programmer to ensure the set up and validation of EDC and CDMS
  • Ensuring data reconciliation is delivered on time and to quality standards
  • Ensure that Medical Coding is being performed
  • Perform database lock and close out activities
  • Mentoring and training junior member of the team
  • Attending kick-off meetings and investigator meeting and as the primary contact with the sponsor in managing protocol execution

Senior Data Manager Requirements:

  • Previous significant experience in Clinical Data Management within a CRO or pharmaceutical company
  • Ideally, Degree level Education
  • Knowledge and experience of the full clinical trial cycle
  • Strong communication skills with the ability to interact with internal and external stakeholder at various levels
  • Experience of mentoring and training junior staff

Similar jobs

Similar jobs