Global Clinical Trial Lead

8 hours ago

Cork, Cork, Ireland beBeeClinical Full time €91,340 - €127,340
Senior Clinical Operations Manager

The Operations Lead oversees the daily operation of the clinical trial capabilities team in support of clinical development.

The lead is accountable for ensuring accurate planning, prioritization across teams, and timely execution working closely with site engagement at the 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 lead provides leadership, direction, and technical support to the Clinical Trial Capabilities specialists, focusing on results and driving efficiency to achieve goals and objectives.

Key Objectives/Deliverables:

  • Accountable for meeting and exceeding targets for clinical trial performance and operations for development programs.
  • Accountable for ensuring 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 team deliverables during site initiation, maintenance, and close-out representing progress to stakeholders.
  • Accountable for daily prioritization of work to meet business needs.
  • Provides 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.
  • Ensure inspection readiness through a complete, accurate, and readily available Trial Master File.

Leadership and Management:

  • Identify and ensure shared learning across the clinical capabilities organization and with other functional groups within the CDO.
  • Build capabilities in the function through the development and improvement of processes, tools, and training.
  • Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning.

People Development and Engagement:

  • Recruit, develop, and retain a skilled and knowledgeable workforce in clinical development.
  • Effectively manage an agile organization that continuously meets the needs of a changing portfolio.
  • Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery.

Qualification Requirements:

  • Bachelor's degree (preferably from a relevant field), six years of clinical research experience or relevant experience essential.
  • Understanding of the overall clinical development paradigm and the importance of efficient site initiation.
  • Previous supervisory experience.
  • Strong leadership skills and ability to influence others and lead across the business.
  • Project management processes and skills.
  • Appreciation of/experience in a compliance-driven environment.
  • Ability to learn and comply with financial and legal guidelines and policies.
  • Effective communication, negotiation, and problem-solving skills.
  • Self-management and organizational skills.

Additional Skills/Preferences:

  • Compliance: Demonstrate a strong compliance-oriented mindset & help to build a strong compliance culture.
  • People: Actively participate in the senior management team to make the organization a great place to work for all employees and influence the strategic direction.
  • Customer: Demonstrate excellence in all interactions with our internal customers & stakeholders.
  • Continuous Improvement: Lead a culture of continuous improvement within the organization.

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