Associate Manager, Clinical Monitoring
Crinetics Pharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $115,000 - $144,000 per year
Job Level
JuniorMid-Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial operationsclinical site managementmonitoring activitiesrisk-based monitoringmonitoring oversight visitscompliance trackingclinical study executionGood Clinical PracticesICH Guidelinesregulatory requirements
Soft skills
leadershipcommunicationwriting skillsorganizational skills
Certifications
BS in biological sciences