Associate Director, Global Monitoring Operations

3 days ago


San Francisco, California, United States Clinical Dynamix Full time
Job Title: Associate Director, Global Monitoring Operations

At Clinical Dynamix, we are seeking an experienced Associate Director to lead our Global Monitoring Operations team. As a key member of our Clinical Operations department, you will be responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies.

Key Responsibilities:
  • Develop and implement monitoring strategies and oversight plans for assigned studies and regions.
  • Collaborate with Clinical Trial Management to ensure compliance with Clinical Monitoring Plans.
  • Conduct monitoring oversight visits and assess CRA performance.
  • Identify and mitigate risks, and ensure resolution of issues at a study, site, or CRA level.
  • Document and track performance indicators and metrics for trends and assessment.
  • Review Monitoring Visit Reports and escalate trends or findings to Clinical Operations study leads.
  • Train and support CRO and/or Company CRA teams on monitoring aspects of the study.
  • Act as a point of escalation for site performance, quality, or compliance problems.
Requirements:
  • Bachelor's degree in a scientific or healthcare discipline.
  • At least 8+ years' experience, with 5+ years as a CRA and 3+ years demonstrated management leadership.
  • Experience monitoring and overseeing Phase 1-3 clinical trials, with a preference for neuroscience, oncology, and/or rare disease therapeutic experience.
  • Demonstrated leadership skills, with the ability to drive results and adapt to change.
  • Excellent communication, interpersonal, and conflict resolution skills.


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