Associate Director, Global Monitoring Operations
3 days ago
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.
- 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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South San Francisco, California, United States Clinical Dynamix Full timeJob Title: Associate Director, Global Monitoring OperationsAt Clinical Dynamix, we are seeking an experienced Associate Director to lead our Global Monitoring Operations team. The successful candidate will be responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies.Key Responsibilities:Develop and implement...
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