Clinical Trial Manager

A clinical-stage biopharmaceutical client based in Santa Clara, California has an exciting opening for a Clinical Trial Manager with experience in CNS/psychiatry.

Company details

This start-up biopharma is developing ground-breaking therapeutics for CNS disorders, including schizophrenia, bipolar disorder and major depressive disorder, which pose significant burdens to patients and their families. You will be part of a team of accomplished professionals in the pharmaceutical industry, who are currently preparing to start global Phase III trials of the company’s lead drug candidate.

Responsibilities

As the Clinical Trial Manager, you will be responsible for multiple studies in neuropsychiatry indications. Additional responsibilities include:

• Monitoring study progress, including timelines, budgets, quality and compliance with SOPs, ICH and GCP guidelines and local regulations
• Monitoring CRO and vendor performance
• Assisting with the development/management of study budgets and contracts
• Managing the TMF and maintaining study documentation
• Providing training and leadership to CRAs and other Clinical Research staff

Required skillsets

• Bachelor of Science
• At least 5 years in clinical trial operations (pharmaceutical or CRO)
• Deep understanding of GCP and ICH guidelines and applicable regulations
• Experience with EDC systems
• Schizophrenia experience preferred

If this position is of interest to you, please apply now or reach out for further details.

Megan Hicks

M.Hicks@x4lifesciences.com