Clinical Development Operations Specialist

7 days ago

Cork, Cork, Ireland beBeeRegulatory Full time €70,000 - €85,000

Job Title: Trial Capabilities Manager

Job Overview

The Trial Capabilities Manager is responsible for leading and managing the daily operation of the clinical trial capabilities team in support of clinical development. The manager ensures accurate planning, prioritization across teams, and timely execution working closely with site engagement at affiliates and across the trial capabilities teams.

The scope includes activities related to investigator sites readiness; maintenance and close out ensuring country-specific requirements are met. The manager is responsible for ensuring inspection readiness through a complete, accurate, and readily available Trial Master File.

Key Responsibilities
  • Meet and exceed goals for clinical trial budgets and contracts operations for development programs.
  • Ensure compliance with local/regional requirements, data privacy requirements, and Lilly quality standards.
  • Manage communications/relationships and serve as the point of contact for the trial capabilities budgets and contracts team deliverables during site initiation, maintenance, and close out representing progress to business partners.
  • Provide expertise in conducting clinical research and keeping up to date with country/regional regulatory requirements.
  • Develop and streamline processes ensuring efficiency and improved productivity as well as meeting customer requirements.

The Trial Capabilities Manager provides leadership, direction, and technical support to the Clinical Trial Capabilities assistants, focusing on results and driving efficiency to achieve goals and objectives.

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