Global TB Clinical Trials Manager - GCP & Quality Lead

UCSF Health, AG; Oakland (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

UCSF seeks a Clinical Trial Manager to lead multicenter tuberculosis diagnostic studies across international sites in Africa and Asia. You will apply extensive GCP knowledge to manage timelines, risks, and regulatory compliance, coordinating cross-functional teams to ensure quality and data integrity.

You will develop, review, and implement SOPs and QMS documents, oversee reporting, submissions, and archival requirements, and foster a culture of quality across the network.

Qualifications

• Bachelor's degree in related area and five years of experience or equivalent training.
• Expert knowledge of GxP (GCP, GLP, GCLP) and regulatory framework for human subjects research.
• Advanced knowledge of clinical research practices and ability to improve methodology.
• Advanced knowledge of regulatory requirements.
• Able to lead multiple projects with competing priorities in a fast-paced international setting.
• Excellent communication, including English and cross-cultural collaboration.
• Experience coordinating multi-site international studies and maintaining audit trails.

Responsibilities

• Act as primary cross-functional liaison across cohorts and teams with international sites.
• Drive study management by overseeing timelines, milestones, and risk mitigation.
• Ensure regulatory compliance and quality through GCP and ISO framework adherence.
• Develop and improve study procedures, SOPs, and QMS documents.
• Prepare study reports, regulatory submissions, and internal documentation.

Skills

GCP Expertise

Clinical Research

Project Leadership

Cross-functional Coordination

Regulatory Knowledge

Education

Bachelor's Degree

Postgraduate Qualification

Tools

Clinical Trial Management Systems

Job description

UCSF seeks a Clinical Trial Manager to lead multicenter tuberculosis diagnostic studies across international sites in Africa and Asia. You will apply extensive GCP knowledge to manage timelines, risks, and regulatory compliance, coordinating cross-functional teams to ensure quality and data integrity.

You will develop, review, and implement SOPs and QMS documents, oversee reporting, submissions, and archival requirements, and foster a culture of quality across the network.