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Associate Director, Global Monitoring Operations
2 months ago
At Clinical Dynamix, we are seeking an experienced Associate Director to lead our Global Monitoring Operations team. This role will be responsible for overseeing the execution and quality of insourced and CRO outsourced studies, as well as managing a team of Clinical Research Associates (CRAs).
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 or arrange for monitoring oversight visits and CRA assessment visits to assess site monitoring activities.
- Proactively identify and resolve issues at a study, site, or CRA level.
- Document and track performance indicators and metrics for trends and to assess CRO and/or Company CRA progress.
- 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 resolution of site performance, quality, or compliance problems.
- Attend CRO oversight or extended study team meetings.
- Bachelor's degree in a scientific or healthcare discipline required; master's degree or higher is a plus.
- At least 8+ years' experience, with at least 5 years as a CRA and 3+ years demonstrated management leadership.
- Experience monitoring and overseeing Phase 1-3 clinical trials; experience in first-in-human trials is a plus.
- Knowledge and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements.
- Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Clinical Dynamix's culture and values.
- Excellent monitoring and leadership experience in startup, execution, and close-out activities related to clinical studies.
- Excellent team player with team building skills and ability to develop strong relationships with internal and external colleagues.
- Superb interpersonal and conflict resolution skills.
- Ability to adapt quickly and effectively to change.
- Ability to demonstrate critical thinking, root cause analysis, and problem-solving to support CRO and/or Company CRAs and study teams.
Clinical Dynamix is an equal opportunities employer and welcomes applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.