Clinical Trial Manager

Job Summary:

The R2D2 TB Network (r2d2tbnetwork.org) is an international research consortium focused on accelerating the development, validation, and adoption of new tuberculosis diagnostics. The R2D2 Team is a multi-institution collaboration with academic and public health partners across the globe, including UCSF, UC Irvine, and Heidelberg University, to conduct GCP-compliant, multi-site diagnostic accuracy studies in high TB-burden countries.

The Clinical Trial Manager for the R2D2 TB Network will apply extensive knowledge of GCP-compliant clinical research protocols and processes to lead, manage, and coordinate the conduct and reporting of multicentric tuberculosis diagnostic accuracy studies across international sites in Africa and Asia. The Clinical Trial Manager will:

• Act as the primary cross-functional liaison across the adult and pediatric cohorts, connecting the Technology, GCP Compliance, Data, and Clinical Support teams with international study sites and sub-contractors to ensure aligned communication and accountability. 
• Drive overall study management by overseeing timelines, tracking milestones, and proactively identifying, documenting, and escalating operational risks with timely mitigation plans. 
• Ensure regulatory and quality compliance by overseeing adherence to ethics standards, GCP requirements, and the R2D2 TB Network quality management framework, including identification, documentation, and escalation of protocol deviations and quality findings with appropriate corrective and preventive action. 
• Own the development, review, and continuous improvement of study procedures, SOPs, and QMS documents supporting GCP, ISO 14155, and ISO 20916 compliance, partnering with the GCP lead to design these systems and with cohort leads to operationalize them at the study level, while driving process improvement and embedding a culture of quality across the network. 
• Direct the preparation of study reports, regulatory submissions, and internal documentation, ensuring study records are maintained accurately and in line with data management and archiving requirements.

Department Summary:

The UCSF Center for Tuberculosis (CTB) unites a multidisciplinary community of TB experts working to accelerate global TB elimination and train the next generation of TB scientists. Since launching in 2019, CTB has grown to include more than 50 faculty investigators across UCSF and UC Berkeley, spanning immunology, data science, epidemiology, pharmacology, diagnostics, therapeutics, biostatistics, implementation science, and policy. As the operational hub of the NIH P30-funded UC Tuberculosis Research Advancement Center, CTB serves as the scientific home for the TB research enterprise at UCSF and beyond. Through cooperative scholarship, technical training, mentorship, clinical excellence, advocacy, and a collaborative spirit, CTB-affiliated faculty, fellows, and staff are advancing global health and improving the lives of TB-affected communities through transformative research and practice.

The Institute for Global Health Sciences (IGHS) is a UCSF campus wide interdisciplinary program that reports to the Chancellor. IGHS is structured as an Organized Research Unit (ORU) and control point that oversees a portfolio of $330M in sponsored programs (including $80-90M per year in grants and cooperative agreements expenses), two graduate groups that confer Masters and PhD degrees, and an administrative unit that provides communication, financial management, event planning, staffing support, operations, and program development support to faculty members working in global health across the campus. 

IGHS's mission is to advance health and reduce health disparities worldwide, with a focus on vulnerable populations. IGHS is continuing to expand its programmatic activities into new regions (Latin America and Asia) and new themes (e.g., transdisciplinary research in infectious disease, maternal and child health, and non-communicable diseases, pandemic preparedness, digital health, climate change, and migrant health). It also is working to develop new educational program offerings (degree and certificate) and partnerships with academic institutions in the US and in low- and middle-income (LMIC) countries. It also has engagements domestically with public health programs, including the California Department of Public Health. 

IGHS is committed to ensuring a diverse, equitable and inclusive work environment as we work towards becoming an anti-racist organization. We strongly encourage applicants from diverse backgrounds. Please see our statement on anti-racism here: https://globalhealthsciences.ucsf.edu/about-us/diversity-equity-and-inclusion/statement-structural-racism

DUTIES & ESSENTIAL JOB FUNCTIONS

Identify the functions or tasks that employees in the job perform. The essential functions should state the purpose of the work and the results to be accomplished, rather than how the function is performed. Of the tasks listed, what percentage of time is devoted to each? The more time employees spend on a function, the more likely it is that the function is essential. Generally, include those functions that account for 10% or more of the work, i.e., key items that contribute significantly to the achievement of the job.  The functions should add up to 100%.

Required:

• Bachelor's degree in related area and five years of experience  or equivalent experience / training.
• Expert knowledge of GxP (GCP, GLP, GCLP) and thorough understanding of the ethical and regulatory framework governing human subjects research.
• Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements.
• Advanced ability to effectively lead one or more projects with competing priorities to meet the demands of a fast-paced and dynamic international work environment. Adaptable to quickly changing priorities.
• Proven ability to coordinate complex, multi-site international studies: skilled in tracking deliverables, managing competing priorities, and maintaining clear documentation and audit trails.
• In-depth critical thinking skills to evaluate issues and identify potential solutions. Creatively addresses complex or new problems.
• Advanced communication skills, including verbal and written English; active listening, critical thinking, persuasiveness, advising, and counseling skills. Clear and concise communicator; culturally responsive and collaborative.
• Advanced interpersonal skills, including problem-solving, teamwork development, and leadership with other team members; ability to build effective working relationships across diverse, international teams.
• Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
• In-depth ability to work collaboratively with other cross-functional teams; ability to interface, collaborate, and influence/persuade other members of an extended, multi-institution study team.

Preferred:

• Postgraduate qualification in a relevant field (e.g., Public Health, Epidemiology, Biomedical Science, or equivalent) and at least 3 years of demonstrated experience managing international, GCP-compliant clinical studies.
• Sound understanding of infectious diseases, particularly tuberculosis, including relevant diagnostic tools, public health context, and evolving trends in the field.
• Familiarity with ISO 20916 and ISO 14155 standards for performance evaluation of in vitro diagnostic medical devices and clinical investigation of medical devices.

• Experience in diagnostic accuracy studies for infectious diseases.