Clinical Project Manager

Posted: June 1, 2016

Job ID: 149

Job Summary

Term: Full-Time
Job Roles: Trial/Study Management
Therapeutic Experience: Infectious Disease
Required Experience: 3 years
Compensation: $100,000-120,000 annually

Job Description

The candidate will be responsible for implementing Phase 1-3 infectious disease vaccine or drug trials for a small biotechnology company in San Diego, reporting to the VP, Clinical Vaccines. Responsibilities include:
• Achieving U.S. Food and Drug Administration (FDA) standards for subject safety and data integrity.
• Managing a Contract Research Organization (CRO) in the conduct of clinical trial(s).
• Fostering effective and collaborative interactions among Clinical and Company employees and with the staff of multiple U.S. trial sites.
• Striving to meet, if not exceed, company timelines.
• Participating in project teams to ensure smooth trial enrollment and expeditious troubleshooting when operational issues arise.
• Working very closely with a small clinical team, apprising senior clinical management on trial status on a daily basis.
• Providing training and oversight to comply with Good Clinical Practice (GCP) guidelines.
In addition to the responsibilities described above, the candidate will:
• Remain current in the latest standards of clinical trial conduct.
• Track issues of clinical operations importance.
• Assist in overseeing multiple contracts and contractors, including a contract research organization (CRO).
• Demonstrate strong organizational and problem-solving abilities in addressing and rectifying operational issues.
• Display firm approach in interacting with CRO, vendors and contractors.