Data and Safety Monitoring Supervisor

Job Summary

The Data and Safety Monitoring (DSM) Supervisor provides strategic leadership for the UC Davis Comprehensive Cancer Center's Data and Safety Monitoring (DSM) program, ensuring the safe, compliant, and high-quality conduct of cancer clinical trials. Reporting to the Executive Director of the Office of Clinical Research (OCR), this role oversees the implementation and administration of the Cancer Center's Data and Safety Monitoring Plan (DSMP), Data and Safety Monitoring Committee (DSMC), Quality Assurance Committee (QAC), centralized clinical trial data management, and the OCR's DSM Unit. This position leads the day-to-day oversight of institutional clinical trial monitoring activities, ensuring participant safety, protocol compliance, data integrity, quality assurance, regulatory readiness, and adherence to federal, state, and institutional requirements. The DSM Supervisor partners with investigators, physicians, biostatisticians, regulatory specialists, informatics teams, and clinical research leadership to build scalable processes, strengthen quality systems, and support operational excellence across the Cancer Center's clinical research portfolio. The DSM Supervisor also provides strategic direction for institutional data management and reporting processes supporting investigator-initiated trials (IITs), interim and final analyses, DSMC review, ClinicalTrials.gov reporting, FDA Investigational New Drug (IND) reporting, audit readiness, and other regulatory reporting requirements. This role plays a critical part in advancing innovative cancer research by fostering a culture of quality, collaboration, continuous improvement, and regulatory excellence.

About the Role

This role plays a critical part in advancing innovative cancer research by fostering a culture of quality, collaboration, continuous improvement, and regulatory excellence.

Responsibilities

• 25% - Clinical Data Governance & Reporting

• 25% - Quality Assurance and Control Oversight

• 25% - Data and Safety Monitoring Oversight

• 25% - Supervision, Training and Change Management

Requirements

• Bachelor's degree in related area and/or equivalent experience/training

• Minimum of five (5) years of progressively responsible experience in clinical research, clinical trial operations, quality assurance, regulatory oversight, clinical trial data management, and/or data and safety monitoring activities within an academic medical center, cancer center, healthcare, pharmaceutical, biotechnology, or related research environment

• Demonstrated experience interpreting and applying federal regulations, Good Clinical Practice (GCP), institutional policies, and clinical research oversight requirements related to clinical trial conduct, quality assurance, safety monitoring, and regulatory compliance

• Experience coordinating complex clinical research activities involving multiple stakeholders, competing priorities, and regulatory requirements

• Leading projects, operational initiatives, process improvement efforts, quality management activities, training programs, and/or cross-functional clinical research operations

• Advanced knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA regulations, NIH/NCI expectations, and clinical trial oversight standards applicable to Phase I-IV and investigator-initiated clinical trials

• Knowledge of current standard-of-care and investigational therapies across multiple oncology therapeutic areas, including complex and novel treatment modalities

• Knowledge and skills in developing, implementing, and overseeing quality management systems, monitoring programs, audit readiness activities, corrective and preventive action (CAPA) processes, and operational improvement initiatives

• Knowledge of clinical trial data management systems, Electronic Data Capture (EDC) platforms, clinical trial reporting processes, and data quality oversight activities

• Ability to interpret complex clinical, operational, safety, and regulatory information and apply critical thinking to identify risks, compliance concerns, operational gaps, and process improvement opportunities

• Demonstrated analytical and problem-solving skills sufficient to independently evaluate complex issues, identify root causes, assess risk, and develop practical operational solutions

• Ability to review, interpret, and analyze large volumes of clinical research, safety, quality, and operational data to identify trends, safety concerns, compliance risks, and quality issues

• Demonstrated ability to independently assess regulatory, operational, safety, and quality risks and exercise sound judgment in complex clinical research oversight situations

• Demonstrated ability to collaborate effectively with investigators, leadership, regulatory personnel, biostatistics, informatics, ancillary departments, sponsors, and multidisciplinary clinical research teams with diverse professional backgrounds

• Excellent organizational skills with the ability to manage multiple complex priorities, adapt to changing operational demands, and function effectively in a fast-paced, deadline-driven environment

• Excellent written, verbal, presentation, and technical communication skills sufficient to effectively develop policies, procedures, reports, training materials, CAPA documentation, committee materials, and other complex scientific and operational documents

• Demonstrated leadership, interpersonal, and change management skills sufficient to lead operational initiatives, influence stakeholders, facilitate cross-functional collaboration, and support organizational growth and process standardization

Qualifications

• Society of Clinical Research Administrators (SOCRA) or Association of Clinical Research Professionals (ACRP) certification (or professional certification in a related field, such as Regulatory, QA, or Clinical Research)

• Master’s degree in related field

Skills

• Knowledge of quality assurance, clinical trial monitoring, data and safety monitoring, and/or clinical trial data oversight within an NCI-designated Comprehensive Cancer Center or other complex academic research environment

• Experience supporting Data and Safety Monitoring Committees (DSMCs), quality assurance programs, centralized monitoring programs, and/or clinical research oversight committees

• Experience with Electronic Data Capture (EDC) systems, eCRF development, clinical trial databases, and clinical research reporting infrastructure

• Experience leading operational process improvement, quality management, training, standardization, or organizational change initiatives within clinical research operations

• Knowledge of National Cancer Institute (NCI) Cancer Center Support Grant (CCSG) guidelines, Clinical Protocol and Data Management (CPDM) expectations, and centralized clinical research oversight models

• Knowledge of quality management systems, monitoring programs, audit readiness activities, corrective and preventive action (CAPA) processes, and operational improvement methodologies applicable to clinical research oversight

• Leadership skills and change management abilities supporting operational standardization, infrastructure development, and continuous improvement within clinical research operations