Clinical Director

4 days ago


Dublin, Dublin City, Ireland Healthcare Businesswomen's Association Full time
Job Description

The Associate Director Clinical Processes & Solutions is responsible for leading and driving operational and scientific excellence through clinical process improvement across the portfolio.

This includes actively driving updates of standard operating procedures, templates, guidance, and trainings.

This position also serves as a clinical representative on cross-functional governance boards and development initiatives.

  • Drive the update of clinical document templates such as Clinical Trial Protocol, Investigator Brochure, Clinical Data Review, and Clinical Development Plan according to clinical guidance.
  • Participate and represent Clinical Development (CD) on important strategic cross-functional projects as defined by CD Leadership Team.
  • Drive cross CD and Global Line Function alignment of processes as part of the deliverables of CD and drive implementation at the Unit level.
  • Lead QA/standard operating procedure (SOP) activities within CD, which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicability; performing collegial reviews of SOPs, templates and processes.
  • Can serve as a Lead SME or as an SME for clinical process-related work such as protocol deviations.
  • Drive best practices by identifying clinical training needs and development opportunities. Identify cross-functional issues, gaps and lead global process improvement work streams as applicable.
  • In collaboration with QA, responsible to implement quality initiatives as needed: inspection readiness, records tracking, support audits preparation and follow up.
  • From a people standpoint, work with the CD to make sure that CD Leadership is informed at all points about key issues and has access to information when needed.


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