Global Clinical Trial Manager

Lakefront Biotherapeutics; San Francisco (CA); On-site; USD 150,000 - 165,000; Full time

Job summary

Lakefront Biotherapeutics in San Francisco is seeking a Clinical Trial Manager to oversee the operational aspects of specific clinical studies from study start‑up through clinical study report, ensuring timelines, budgets, quality of deliverables, and regulatory compliance.

You will organize study team meetings, select CROs and vendors, oversee vendor training and the development of protocols and study plans, and partner with data management to maintain data quality and timely entry.

Qualifications

• BS/BA in the life sciences or a related field.
• 5–7 years of clinical operations experience in the biotech/pharma industry; autoimmune/rare disease experience highly desirable.
• Direct global study management experience preferred.

Responsibilities

• Own clinical study execution and oversight of all operational aspects.
• Organize and lead study team meetings for clear communication and risk mitigation.
• Identify and select CROs and third‑party vendors.
• Oversee CROs and vendors to ensure study execution.
• Ensure vendor training on study documents.
• Develop study documents (protocols, amendments, ICFs, plans) with cross‑functional teams.
• Maintain excellent relationships with investigators and study staff.
• Ensure studies comply with protocol, SOPs, ICH/GCP.
• Participate in feasibility for new sites.
• Review CRFs and database build to reflect the study in the database.
• Review key study quality metrics and take action with study team.
• Collaborate with Data Management for data quality and timely data entry.
• Manage study budget and invoices; approve vendor changes.
• Provide study guidance to internal and external partners.
• Other duties as assigned.

Skills

Global trial management

Project coordination

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in life sciences

Tools

EDC systems

IRT

TMF

CTMS

Job description

Lakefront Biotherapeutics in San Francisco is seeking a Clinical Trial Manager to oversee the operational aspects of specific clinical studies from study start‑up through clinical study report, ensuring timelines, budgets, quality of deliverables, and regulatory compliance.

You will organize study team meetings, select CROs and vendors, oversee vendor training and the development of protocols and study plans, and partner with data management to maintain data quality and timely entry.