The Clinical Development & Analytics Associate Director (CD&A-AD) is responsible for leading and driving operational and scientific excellence through data standards, and process improvement in CD&A across all Development Units. This includes but is not limited to actively driving updates of clinical processes (process improvement, SOP development) and document templates. The CD&A-AD will also serve as a clinical representative on cross-functional governance boards and development initiatives (including other line function initiatives).
Drive the update of clinical documents template such as Clinical Trial Protocol, Informed Consent, Investigator Brochure and Integrated Development Plan according to clinical guidance
Participate and represent CD&A on important strategic cross-functional projects as defined by CD&A Leadership Team.
Drive cross Development Unit alignment of processes as part of the deliverables of CD&A and drive implementation at the Unit level.
QA/SOP activities within CD&A, serve as clinical representative on Process, Training & Governance Board (PTGB) which includes coordinating Subject Matter Experts (SME) identification; applying clinical applicabilities; performing collegial reviews of SOPs and P&SPs.
Can serve as a Lead SME or as an SME.
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.
Drive efficiency and track performance against metrics
From a people standpoint, work with the CD&A to make sure that CD&A Leadership is informed at all points about key issues and has access to information when needed