• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Clinical Operations Leader

Job Number: 34645

Location:

Job Description

Reporting to the Head of Clinical Operations, the Clinical Operations Leader (COL) will provide strategic leadership to ensure successful operational execution of clinical trials at an organization. The COL will serve as a functional lead, line manager, and subject matter expert for the Clinical Operations team. Responsibilities include developing operational plans, managing clinical studies, ensuring compliance with protocols and regulations, and managing team members. The COL will also collaborate with senior leaders to improve processes and procedures.

Responsibilities

Key responsibilities include:

  • Trial Oversight: Directly manages Clinical Operations staff for clinical trial execution, ensuring compliance with ICH/GCP requirements and industry standards.
  • Risk Management: Guides risk management strategies, resolves study-related issues, and ensures readiness for inspections.
  • People/Functional Management: Develops resourcing plans, recruits and trains team members, and supports career development.
  • Financial Oversight: Drives budget planning and conducts routine budget reviews for assigned programs.
  • Program Strategy: Contributes to operational strategies in the Clinical Development Plan for assigned programs.
  • Process Improvement: Leads initiatives to enhance department infrastructure and improve processes and procedures.

Required Skills

  • 15+ years of Clinical Operations experience in biotech, pharmaceuticals, or CRO, including 5+ years of people management.
  • Minimum B.A./B.S. degree in a relevant field or nursing.
  • Strong people management, coaching, and mentoring skills.
  • Experience in CRO oversight, vendor selection, contract negotiation, and budget management.
  • In-depth knowledge of guidelines and regulations.
  • Global experience, especially in developing countries and target populations.
  • Infectious Diseases or Vaccines experience is beneficial.
  • Effective communication and leadership skills.
  • Passion for the organization's values and mission.
  • Willingness to travel locally and internationally (around 5-10%).

 

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