Clinical Trials Operations Manager

hace 7 días

Bogotá, Bogotá D.E., Colombia IQVIA A tiempo completo

Job Overview

As a key member of the IQVIA team, the Centralized Monitoring Lead will provide leadership and guidance to the centralized monitoring team to ensure the successful delivery of clinical trials. This role will work closely with project and clinical leads to achieve project objectives, optimize speed, quality, and cost of delivery, and ensure compliance with IQVIA standard operating procedures, ICH GCP guidelines, and regulatory requirements.

Key Responsibilities

  • Project Oversight: Oversee clinical deliverables on assigned projects, manage project resources, and coordinate efforts of cross-functional project teams.
  • Quality Assurance: Ensure subject safety, data integrity, and compliance with relevant regulations and guidelines. Conduct regular quality checks and manage audit initiatives.
  • Communication: Act as a point of contact for assigned deliverables and establish effective project/site level communications.
  • Risk Management: Identify and mitigate risks associated with project deliverables. Monitor site performance and recommend corrective actions.
  • Mentorship: Act as a mentor for junior staff and Technical Solution Specialists.
  • Training: Act as a Subject Matter Expert to support departmental training.

Qualifications

  • Bachelor's degree in life sciences or related field.
  • Minimum of 5 years of relevant experience in clinical trial management.
  • Formal or informal leadership experience.
  • Advanced knowledge of clinical trial conduct and applicable clinical research regulatory requirements.
  • Strong written and verbal communication skills.
  • Ability to work on multiple projects and manage competing priorities.
  • Strong organizational, problem-solving, and decision-making skills.
  • Ability to work across cultures and geographies.

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