Job Description:
• 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
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Apply Now