Associate Manager, Clinical Monitoring
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Job Description
Associate Manager, Clinical Monitoring overseeing clinical trial operations and clinical site management activities at Crinetics. Supporting global and regional trials with a focus on endocrine diseases.
Responsibilities:
- support global and regional clinical trial operations (CTO)
- conduct and oversight of clinical site management and monitoring activities
- implement strategy for in-house, regional monitoring activities applying a risk-based approach
- lead monitoring activities on assigned studies
- manage the CRA monitoring visit schedule for each assigned study
- track and report to study team on compliance, trends and metrics related to monitoring and site management
- manage or conduct monitoring oversight visits (MOVs)
Requirements:
- BS in biological sciences or related discipline
- at least 5 years of experience working in the biotechnology/pharmaceutical industry
- Monitoring experience in startup, execution and close out activities related to clinical studies
- experience using risk-based monitoring processes strongly preferred
- Previous experience as a Lead CRA, Trial Manager, or equivalent strongly preferred
- An understanding and demonstrated application of Good Clinical Practices, ICH Guidelines and regulatory requirements
- In-depth experience with cross functional drug development with prior regulatory inspection experience preferred
- Excellent writing skills as they relate to the preparation of clinical trial documents
Benefits:
- discretionary annual target bonus
- stock options
- ESPP
- 401k match
- top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- winter company shutdown
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