Clinical Trial Manager, Phase 3
Crinetics Pharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $122,000 - $152,000 per year
Job Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Responsible for executing phase 3 clinical studies and data collection
- Provide oversight of late-phase clinical research studies
- Develop subject recruitment/retention strategy
- Oversee TMF set-up and quality review
- Create training materials for study teams and vendors
- Ensure compliance with ICH/GCP regulations
- Prepare RFPs and negotiate contracts with CROs/vendors
- Perform study risk management and implement solutions
- Maintain focus on strategic objectives while accomplishing operational goals
Requirements
- Bachelor’s degree required
- 7 years of clinical operations experience, preferably with CRO/small biotech experience
- 2 years in a supervisory role
- Computer skills: Proficiency with Microsoft Office suite, electronic TMF systems, IXRS, and EDC systems
- Excellent understanding of the drug development process
- Effective verbal and written communication skills
- Experience with FDA regulatory requirements (GCPs, CFRs, etc.)
- Ability to handle multiple tasks and meet deadlines
- Ability to exercise judgment and determine appropriate action
Benefits
- Health insurance plans (medical, dental, vision) for employees and their families
- 401(k) matching
- Discretionary annual target bonus
- Stock options
- 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 operationsdata collectionsubject recruitment strategyrisk managementcontract negotiationdrug development processGCP complianceCFR compliance
Soft skills
supervisory skillseffective communicationjudgmentmultitaskingdeadline management