Clinical Operations Leader

2 weeks ago

Cork, Cork, Ireland beBeeSeniorManager Full time €95,723 - €128,617
Job Opportunity:

Unlock a fulfilling career path as a Senior Manager, where you will oversee clinical trial capabilities supporting clinical development. This role ensures investigator sites meet enrollment requirements and support activities during site maintenance and close-out, including regulatory submissions and serving as a point of contact for ERBs and Competent Authorities where applicable.


As a Senior Manager, you will plan, prioritize, and implement site initiation activities, collaborating with global and affiliate teams to ensure timely and accurate execution aligned with portfolio needs.


You will provide leadership and technical support to Clinical Trial Capabilities Teams, focusing on results and efficiency, and ensure inspection readiness with a complete, accurate Trial Master File.


Key Responsibilities:

  • Meet and exceed clinical trial initiation goals for development programs.
  • Ensure site activities comply with regional requirements, data privacy, and standards.
  • Create and deliver site activation strategies.
  • Manage communications and serve as the primary contact during site initiation, maintenance, and close-out, reporting progress to stakeholders.
  • Prioritize work to meet portfolio needs.
  • Allocate resources flexibly across teams and geographies.
  • Maintain expertise in clinical research and regional regulatory requirements.
  • Develop strategies to enhance customer experience.
  • Ensure inspection readiness with a complete Trial Master File.

Leadership Expectations:

  • Promote shared learning across the clinical capabilities organization and other functions within CDO and MDU.
  • Build organizational capacity through process, tool, and training improvements, leveraging technology for increased efficiency.
  • Foster a culture of continuous improvement in process, skills, and shared learning.

People Management and Development:

  • Recruit, develop, and retain a skilled workforce in clinical development.
  • Manage an agile organization responsive to changing portfolios.
  • Cultivate an inclusive, innovative culture that values sound judgment in clinical delivery.

Requirements:

  • Bachelor's degree in a scientific or health-related field; five years of clinical research or relevant experience preferred.
  • Understanding of clinical development and site initiation importance.
  • Previous supervisory experience.
  • Strong leadership, influence, and project management skills.
  • Experience in compliance-driven environments.
  • Ability to understand and adhere to guidelines.
  • Effective communication, negotiation, and problem-solving skills.
  • Organizational and self-management skills.
  • Language skills are preferred.

Our organization is committed to accommodating individuals with disabilities. If you require assistance with the application process, please let us know.


Equal opportunity employer

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