Clinical Trial Manager, Phase 3
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 Apply tot his job