Clinical Project Manager
Job Code 201703
The candidate will be responsible for implementing Phase 1-3 infectious disease drug and/or vaccine trials for a small biotechnology company in San Diego, reporting to the VP, Clinical Vaccines.
- 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 a daily basis regarding trial status.
- 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.
- Travel to sites as needed; at times up to 30%.
The successful candidate must have:
- A Bachelor’s or Master’s degree in a relevant scientific or health-related field.
- A minimum of four (4) years of clinical project management and CRO management experience within the biotech/pharmaceutical industry.
- Experience in clinical monitoring preferred.
- Experience in conducting or overseeing multi-site, hospital-based trials.
- Antibacterial / antifungal trial experience strongly preferred.
- Experience in contributing to the design of trial documents including, but not limited to: clinical protocols, informed consent forms, case report forms, site study manuals, and project/tracking tools.
- Experience in conducting trials in the EU preferred.
- Ability to perform effectively in a team environment, collaborating professionally with other departments such as Regulatory Affairs, and Quality Assurance.
- Strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) regulations, and International Committee on Harmonisation (ICH) guidelines.
- Excellent oral and written communication skills.
- Proficiency in basic computer programs (e.g. MS Word, Excel, PowerPoint, Project).
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Vical is committed to a policy of equal employment opportunity. In keeping with our policy, Vical will recruit, hire, train and promote into all job titles the most qualified individuals, without regard for race, color, religion, sex, sexual orientation, national origin, ancestry, age, marital status, veteran status, disability, medical condition, usage of family and medical leave, or usage of pregnancy disability leave.