Senior Clinical Trial Manager

Canopy Life Sciences is a well-respected vendor & partner in the life sciences industry, assisting pharmaceutical and life sciences clients in various functional areas of expertise. We have been named for the past 4 years, to the Inc 5000 quickest growing private companies. Our culture is one of empowerment. Everyone has a voice and plays a role in the success of the business and a role in developing our values & behaviors. We recruit, train, and develop people to ensure the very best for our client partners.

Senior Clinical Trial Manager

Location: San Diego is preferred (Possibly open to West Coast)

Job Summary

The Senior Clinical Trials Manager oversees and manages the operational aspects of one or more clinical studies, from the development of protocols to the locking of the database. They ensure that clinical studies are conducted on time and in compliance with protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all relevant regulations and guidelines. This role involves supervising the Contract Research Organization (CRO) and other third-party vendors for their assigned study. Additionally, this position provides expertise to internal teams such as regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing to ensure quality processes and deliverables. The position is preferably based in San Diego, with remote options available depending on the level of experience.

Clinical Trial Experience

• Oversee and execute operational aspects of clinical studies from protocol development to database lock
• Ensure studies comply with protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and applicable regulations and guidelines
• Provide oversight of CROs and third-party vendors
• Develop and maintain good working relationships with CROs, investigators, and study staff
• Ensure timely conduct of clinical studies and timely response to queries and monitoring discrepancies
• Track and report study progress, including site activation, patient enrollment, monitoring visits, and data submission backlogs
• Perform clinical data review, including query generation
• Review and approve investigational product (IP) release packages
• Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals, guides, and electronic case report forms
• Plan and conduct investigator meetings
• Review and approve third-party study vendor invoices
• Ensure audit-ready condition of clinical trial documentation
• Collaborate with cross-functional teams (Medical Monitor, Regulatory Affairs, CRO, vendors, Investigators/site staff)
• Manage clinical monitoring activities ensuring compliance with ICH/GCP and applicable regulations

Salary Range:

$155,000 - $165,000 (DOE)