Senior Clinical Operations Lead

7 days ago

Cork, Cork, Ireland beBeeClinical Full time €80,000 - €100,000
Leadership Role for Clinical Trials

The Clinical Trial Manager - Operations is responsible for overseeing and managing the daily operations of a clinical trial capabilities team in support of clinical development. This role entails ensuring accurate planning, prioritization across teams, and timely execution working closely with site engagement at affiliates and across trial capabilities teams.

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

Key Objectives/Deliverables:

  • Accountable for meeting and exceeding goals for clinical trial operations for development programs.
  • Ensure compliance with local/regional requirements, data privacy requirements, and quality standards.
  • Manage communications/relationships and serve as the point of contact for the trial capabilities operations team deliverables during site initiation, maintenance, and close out representing progress to stakeholders.

Organizational Leadership:

  • Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the company.
  • Build capabilities in the function through the development and improvement of processes, tools, and training.

People Management and Development:

  • Recruit, develop, and retain a capable workforce skilled and knowledgeable in clinical development.
  • Effectively manage an agile organization that continuously meets the needs of a changing portfolio.

Qualification Requirements:

  • Bachelor's degree (preferably from legal/health science/finance/engineering field), six years clinical research experience or relevant experience essential.
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation.

Additional Skills/Preferences:

  • Demonstrate a strong compliance-oriented mindset and help build a strong compliance culture.
  • Actively participate in senior management to make the company a great place to work for all employees and influence the strategic direction.

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