Clinical Data Manager

Job Description

The Pediatric Neuro-Oncology Consortium (PNOC) Clinical Data Manager (CDM) provides strategic leadership and operational oversight for all clinical data systems and data management functions within the PNOC Operations Office, under the direction of PNOC Leadership. The CDM oversees the Clinical Research Coordinator (CRC) team and is accountable for ensuring that clinical trial data are collected, maintained, and reviewed in accordance with PNOC-defined data quality standards, regulatory requirements, and best practices. The CDM ensures that data generated by PNOC studies are complete, accurate, traceable, and suitable for downstream analysis, publication, and responsible data sharing.

In collaboration with PNOC Leadership, the CDM defines group goals and objectives related to clinical data systems, data quality standards, and operational efficiency. The CDM develops projections for deliverables and achievements and continuously evaluates incoming and ongoing protocols, projects, meetings, and emerging opportunities to support the continued growth and improvement of both the team and the consortium overall. This includes assessment of protocol feasibility, data collection requirements, and alignment with PNOC standards for analysis, publication, and data dissemination.

The CDM is accountable for the stewardship of human and financial resources related to clinical data operations, ensuring that adequate resources are available to meet program priorities and communicating proactively when additional support is required.

This position functions with a high degree of autonomy and minimal supervision and works in close partnership with PNOC Leadership, to whom the role reports. The CDM is expected to bring subject matter expertise in pediatric neuro-oncology; clinical trials and clinical trial management; clinical data systems and data quality oversight; regulatory requirements at the local, national, and international levels; collaboration with industry sponsors; budget development and expenditure oversight; coverage analysis; principles of data integrity and standardization; and the intersection of clinical care and clinical research. The role requires comprehensive knowledge of institutional policies and procedures, as well as national and international regulatory frameworks. The CDM collaborates with UCSF campus committees and departments to ensure compliance and to advocate for the unique operational needs of the consortium. The CDM maintains strong communication with current PNOC member sites, prospective sites (domestic and international), collaborators, foundations and supporters, and industry partners.

The CDM maintains familiarity with all actively enrolling clinical trials, studies in development, and studies in analysis and manuscript preparation, and works with investigators and study teams to ensure that data collected across studies meet PNOC standards for analysis, reporting, publication, and responsible data sharing.

The CDM oversees the development of project plans and directly manages the activities of assigned staff, providing leadership, guidance, and performance oversight. The CDM ensures staff are appropriately trained, understand applicable policies and procedures, and are supported in meeting program goals, including adherence to PNOC data quality and documentation standards. The CDM identifies and implements process improvements to optimize data accuracy, consistency, efficiency, and timelines, and develops both short- and long-term strategic plans to support the objectives and mission of PNOC.

Department Overview

The Pediatric Neuro-Oncology Consortium (PNOC) was founded in 2012 in response to the growing need for innovative research in children/young adults with brain cancer. The consortium is a collaborative effort between twenty-three domestic institutions as well as international institutions in Europe, Australia, Canada, India, and Israel. The Operations Office for PNOC provides leadership and manages the infrastructure of the consortium and is nested under the UCSF Department of Neurology and Department of Neurosurgery.

Qualifications

Required Qualfications - BA/BS with a major in a related field and minimum five years of experience in project management, clinical research, administrative analysis or operations research; and three years of supervisory/lead experience or an equivalent combination of education and experience. - Strong communication and interpersonal skills to communicate with leadership, and lead and direct subordinates. Strong interpersonal skills, judgment, and diplomacy when communicating with staff and faculty at different levels of an organization and an ability to work with diverse groups, including physicians, researchers, faculty, fellows, students, nurses, and support staff. - Thorough knowledge of organization processes, protocols, research and procedures. - Extensive analytical / problem-solving skills. - Knowledge of Code of Federal Regulations and Good Clinical Practice as it relates to clinical trials in Oncology. - Knowledge of federal, state and local research regulations and guidelines involving human subject research. - Knowledge of medical terminology, and the ability to apply it to the assessment, interpretation, and processing of medical data. - Analytic and organizational skills that allow the ability to prioritize several different tasks, managing each task from beginning to completion. - Demonstrated exceptional attention to detail. - Proven ability to be self-motivated and perform effectively under the pressure of deadlines and multiple competing projects. - Excellent computer skills and demonstrated proficiency working with programs like the Microsoft Office Suite, along with a strong ability and willingness to learn new software. - Experience with database management, relational databases, and/or designing queries and forms for accurate data collection and analysis. - Experience working with Oncology patients and/or experience working in medical setting, either office or hospital. Preferred Qualifications - Technical writing and editing skills. - Prior UCSF experience in project management or clinical research.