Overview

Reference Number: JO-2107-473235
Senior Clinical Study Lead
Rate: £75,000 – 80,000
Job Type: Permanent
Location: Hillingdon, Uxbridge

Senior Clinical Study Lead
Uxbridge or Dublin Hybrid Working
Permanent
Salary: Circa 80,000 + benefits

Are you a Senior Clinical Project Manager looking for your next career step?

We are looking for a Senior Clinical Study Lead to join a leading biotech within their Oncology function. You will lead the cross-functional study team responsible for complex, global clinical trials from study design to close out, within both internally sourced studies and studies outsourced to CROs. We need experienced individuals who have experience managing Third-Party Vendors and can contribute to and drive process improvement initiatives that support the rapidly growing organization.

Key Responsibilities

  • Leading and contributing to the development of all study specific documentation including CRF, data management plan, monitoring plan etc.
  • Supervising the set-up and maintenance of study systems including CTMS, TMF.
  • Input into the budget and timeline development
  • Managing feasibility assessments, site evaluation and selection
  • Leading investigator meetings
  • Managing progress of site activation and monitoring visits including control of any deviations from plan
  • Manage the development and implementation of patient recruitment and retention
  • Ensuring quality data through regular review of data metrics, protocol deviation and any non-compliances
  • Managing clinical project audit and inspection readiness throughout study and rectification of CAPAs as necessary
  • Supervising close-out activities including study reports and review.
  • Direct supervision of Clinical Trial Management staff.

Key Requirements

  • Oncology therapy area experience early phase desirable.
  • Direct management experience in managing global clinical trial operations, including developing protocols and key study documents
  • Relevant bachelors degree
  • Minimum of 8 years relevant industry experience
  • Knowledgeable and competent in trial management software and MS applications.

This is an exciting time to join this rapidly growing organization and have a direct impact on bringing life-saving treatments to the market. The role is currently 100% home based working but will require office working 3 days per week as restrictions ease, either based in Uxbridge or Dublin.

If this role is of interest, please send your CV to hanna.poole@cpl.com or call 0118 952 2793 for more information.

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