Associate Director, Clinical Monitoring
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Job Description
Associate Director of Clinical Monitoring overseeing study execution and quality oversight in a pharmaceutical company. Leading clinical monitoring activities and ensuring compliance with regulatory requirements.
Responsibilities:
- Responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies
- Provide leadership support to clinical study teams and/or CMMs with study execution and oversight related to Clinical Monitoring
- Lead team in building strong relationships with Principal Investigators, site staff, and vendors
- Define and track metrics and key performance indicators (KPIs) to assess study performance and operational efficiency
- Manage and lead CMMs and assigned Crinetics and FSP Clinical Research Associates (CRAs)
- Ensure adequate resourcing for all CRAs and CMMs across assigned studies/program
- Conduct annual performance assessment activities for direct reports
- Responsible for all Clinical Monitoring recruiting activities
- Lead selection of clinical monitoring vendors; support invoice review of clinical monitoring vendors
- Deliver high quality Clinical Monitoring activities for both insourced and outsourced studies
Requirements:
- BS in biological sciences or related discipline
- At least 10 years of experience working in the biotechnology/pharmaceutical industry
- A minimum of 7 years in a supervisory role
- Experience in all stages of drug development/pharma (study start-up, maintenance, database lock etc.)
- Strong understanding of clinical trial processes, protocols, and medical terminology
- Experience using risk-based monitoring processes highly desired
- Demonstrates critical thinking, root cause analysis and problem solving
- Deep understanding and demonstrated application of Good Clinical Practices, ICH Guidelines, and regulatory requirements
- Excellent writing skills as they relate to the preparation of clinical trial documents
- Familiarity of Regulatory Affairs as applicable to clinical data and report filings
Benefits:
- Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- Discretionary annual target bonus
- Stock options
- 401k match
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
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