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.

Responsibilities

of time
Essential Function (Yes/No ) Key Responsibilities (To be completed by Supervisor)10 Yes
Evaluates new and prospective PNOC member sites from a clinical data and data quality perspective to assess readiness for participation in PNOC clinical trials and data sharing initiatives.

• Reviews site capabilities related to data collection, data quality, regulatory compliance, and use of clinical data systems
• Assesses alignment with PNOC data standards, documentation practices, and reporting expectations
• Identifies potential data quality, regulatory, or operational risks associated with onboarding new sites
• Collaborates with PNOC Leadership and Operations staff to recommend onboarding strategies and resource needs
• Meets with prospective site staff to review data workflows, identify bottlenecks, and support timely activation of PNOC clinical trials
• Provides training and guidance to new and existing sites on PNOC data standards, SOPs, and expectations to ensure compliant data collection

10 Yes
Receives protocol concepts and project plans from PNOC Leadership and provides data-focused review and oversight prior to assignment and implementation.

• Reviews new protocol concepts to assess data collection complexity, feasibility, and alignment with PNOC data quality and publication standards
• Evaluates anticipated data volume, number of participating sites, study design, and sponsor requirements to inform resourcing needs
• Recommends changes to policies, workflows, or data collection approaches that affect major portions of the consortium or research initiatives
• Collaborates with PNOC Leadership to ensure studies are designed to support high-quality analysis, publication, and data sharing
• Identifies opportunities to standardize data elements and processes across studies to improve efficiency and consistency

30 Yes
Provides direct supervision and leadership to Clinical Research Coordinator (CRC) staff responsible for data collection and clinical trial execution.

• Manages performance, training, and professional development of CRCs with a focus on data quality and protocol compliance
• Provides guidance and escalation support for complex data-related issues across multiple studies
• Assigns CRC responsibilities to promote specialization (e.g., data entry, query resolution, imaging, regulatory documentation) and improve efficiency
• Oversees alignment of case report forms and data collection practices across studies
• Reviews data quality metrics, audit trails, and monitoring findings to identify trends and corrective actions
• Ensures staff understand and adhere to PNOC data standards, SOPs, and documentation requirements

10 Yes
Develops, coordinates, and communicates policies and guidance related to clinical data systems, data quality, and regulatory compliance.

• Drafts and disseminates guidance to PNOC sites regarding data standards, data corrections, and documentation expectations
• Synthesizes sponsor- and study-specific requirements into clear consortium-wide guidance
• Supports education and implementation of new or updated data-related policies and procedures
• Serves as a subject matter expert for PNOC Leadership on data integrity and compliance considerations

10 Yes
Manages data-related project planning and resource oversight, ensuring alignment with study budgets, timelines, and data quality objectives.

• Reviews data-related aspects of study budgets and coverage analyses in collaboration with project and operations staff
• Monitors study-level data workload and resource utilization
• Partners with PNOC Leadership to identify gaps in staffing or systems needed to meet data quality and reporting expectations
• Reviews study progress to ensure data deliverables support analysis, publication, and sponsor requirements
• Participates in hiring decisions, performance evaluations, and salary actions for managed staff
• Ensures equitable distribution of workload and opportunities for growth and specialization
• Promotes staff recognition and professional development through UCSF programs and awards
• Fosters a collaborative and supportive team culture focused on quality and continuous improvement

5 Yes Performs personnel management and staff development functions for direct reports.15 Yes
Consortium Data Liaison

• Serves as a primary point of contact for PNOC sites regarding data systems, data quality expectations, and reporting requirements
• Coordinates with investigators, CRCs, and data stakeholders across all PNOC sites to gather, evaluate, and disseminate data-related information
• Oversees data-related onboarding of new PNOC sites, including access to systems and required training
• Delegates administrative components of access setup while retaining oversight of data access controls to ensure security and integrity
• Supports PNOC meetings and working groups by providing data-related content, metrics, and guidance

5 Yes
Online Data Resources and Documentation

• Oversees development and maintenance of data-related guidance, documentation, and resources available to PNOC sites
• Ensures published materials related to data standards and trial participation align with UCSF policies and branding requirements
• Delegates routine maintenance activities while retaining responsibility for accuracy and compliance of posted content

5 Yes
Innovation and Continuous Improvement in Data Operations

• Evaluates current PNOC data workflows and systems to identify opportunities for improved efficiency, accuracy, and consistency
• Develops recommendations to support the strategic direction of PNOC data operations
• Interprets and implements new institutional, sponsor, and regulatory data-related policies
• Participates in institutional and multi-center working groups related to clinical data best practices
• Leads evaluation and adoption of new tools, systems, or technologies (including AI-enabled solutions where appropriate) to enhance data quality and operational efficiency, ensuring compliance with data privacy and regulatory requirements

100% (To update total %, enter the amount of time in whole numbers (without the % symbol - e.g., 15, 20) then highlight the total sum (e.g., 1%) at the bottom of the column and press F9. The total sum should add up to 100%.)

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.