Data and Safety Monitoring Supervisor

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.

Apply By Date: August 1, 2026, at 11:59 PM

Minimum Qualifications - For full consideration, applicants are encouraged to upload a license and/or certification if required for the position.

• 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
• Experience leading projects, operational initiatives, process improvement efforts, quality management activities, training programs, and/or cross-functional clinical research operations
• Strong knowledge of clinical trial design, clinical research operations, safety oversight, quality assurance methodologies, and applicable regulatory requirements governing oncology clinical research
• 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

Preferred 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) or equivalent
• Master's degree in related field
• Experience within an NCI-designated Comprehensive Cancer Center, academic medical center, and/or community oncology research program
• Experience with investigator-initiated trials (IITs), including quality assurance, monitoring, audit readiness, clinical trial data management, interim analysis support, ClinicalTrials.gov (CT.gov) reporting, and/or Food and Drug Administration (FDA) Investigational New Drug (IND) reporting activities
• Experience supporting Data and Safety Monitoring Committees (DSMCs), quality assurance programs, centralized monitoring programs, and/or clinical research oversight committees
• Experience preparing for, coordinating, or supporting FDA, sponsor, National Clinical Trials Network (NCTN), Institutional Review Board (IRB), or other regulatory audits and inspections
• 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 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
• Ability to support investigator-initiated trials (IITs), including protocol oversight, audit readiness, clinical trial data management, interim analysis support, ClinicalTrials.gov (CT.gov) reporting, and/or Food and Drug Administration (FDA) Investigational New Drug (IND) reporting activities
• 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
• Ability to work collaboratively in a multidisciplinary, matrixed academic or healthcare environment with cross-functional operational and scientific teams
• Leadership skills and change management abilities supporting operational standardization, infrastructure development, and continuous improvement within clinical research operations

Key Responsibilities

• 25% - Clinical Data Governance & Reporting
• 25% - Quality Assurance and Control Oversight
• 25% - Data and Safety Monitoring Oversight
• 25% - Supervision, Training and Change Management

Department Overview

The UC Davis Comprehensive Cancer Center (UCDCCC) is a campus-wide multidisciplinary matrix organization whose mission is to reduce the burden of cancer among the diverse populations in our community and beyond through bidirectional engagement and transdisciplinary collaborations that enhance our understanding of cancer, inform new ways to prevent and treat cancer, and prepare a committed and inclusive workforce. The Office of Clinical Research (OCR) is the centralized office for clinical research operations within UCDCCC. The OCR services support the entire lifecycle of cancer-related clinical research protocols. These include support for development and implementation of clinical trials, quality control of clinical research operations, and training and education services.

POSITION INFORMATION

• Salary or Pay Range: $3,371.64 - $ 6,210.72
• Salary Frequency: Bi-weekly
• Salary Grade: 23
• UC Job Title: RSCH CMPLNC SUPV 2
• UC Job Code: 006233
• Number of Positions: 1
• Appointment Type: Career
• Percentage of Time: 100% Full-time
• Shift (Work Schedule): Monday- Friday (8 AM - 5 PM)
• Location: Facilities Support Srvcs Bldg, Sacramento, CA
• Union Representation: Non-Represented (PPSM)
• Benefits Eligible: Yes
• This position is hybrid (mix of on-site and remote work): Must be onsite 2-3 days per week.

Benefits

Outstanding benefits and perks are among the many rewards of working for the University of California. UC Davis offers a full range of benefits, resources and programs to help you bring your best self to work, as well as to help you and your family achieve your health, wellness, financial and career goals. Learn more about the benefits below and eligibility rules by visiting either our handy Benefits Summary for UC Davis Health Employees or Benefits Summary for UC Davis Employees and our Benefits Page.
If you are represented by a union, benefits are negotiated between the University of California (UC) and your union and finalized in a contract. Read your bargaining unit's employment contract, stay abreast of current negotiations and learn about collective bargaining at UC: https://ucnet.universityofcalifornia.edu/labor/bargaining-units/index.html.

• High quality and low-cost medical plans to choose from to fit your family's needs
• UC pays for Dental and Vision insurance premiums for you and your family
• Extensive leave benefits including Pregnancy and Parental Leave, Family & Medical Leave
• Paid Holidays annually as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Paid Time Off/Vacation/Sick Time as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Continuing Education (CE) allowance and Education Reimbursement Program as stipulated in the UC Davis Health Policies or Collective Bargaining Agreement
• Access to free professional development courses and learning opportunities for personal and professional growth
• WorkLife and Wellness programs and resources
• On-site Employee Assistance Program including access to free mental health services
• Supplemental insurance offered including additional life, short/long term disability, pet insurance and legal coverage
• Public Service Loan Forgiveness (PSFL) Qualified Employer & Student Loan Repayment Assistance Program for qualified roles
• Retirement benefit options for eligible roles including Pension and other Retirement Saving Plans. More information on our retirement benefits can be found here

Physical Demands

• Standing - Occasional Up to 3 Hours
• Walking - Occasional Up to 3 Hours
• Sitting - Frequent 3 to 6 Hours
• Lifting/Carrying 0-25 Lbs - Occasional Up to 3 Hours
• Bending/Stooping - Occasional Up to 3 Hours
• Squatting/Kneeling - Occasional Up to 3 Hours
• Twisting - Occasional Up to 3 Hours
• Reaching overhead - Occasional Up to 3 Hours
• Keyboard use/repetitive motion - Frequent 3 to 6 Hours

Mental Demands

• Sustained attention and concentration - Continuous 6 to 8+ Hours
• Complex problem solving/reasoning - Continuous 6 to 8+ Hours
• Ability to organize & prioritize - Continuous 6 to 8+ Hours
• Communication skills - Continuous 6 to 8+ Hours
• Numerical skills - Occasional Up to 3 Hours
• Constant Interaction - Frequent 3 to 6 Hours
• Customer/Patient Contact - Occasional Up to 3 Hours
• Multiple Concurrent Tasks - Frequent 3 to 6 Hours

Work Environment

• UC Davis is a smoke- and tobacco-free campus effective January 1, 2014. Smoking, the use of smokeless tobacco products, and the use of unregulated nicotine products (e-cigarettes) will be strictly prohibited on any UC Davis-owned or leased property, indoors and outdoors, including parking lots and residential space.

Special Requirements - Please contact your recruiter with questions regarding which activities apply by position.

Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.

A Culture of Opportunity and Belonging

At UC Davis, we're committed to solving life's most urgent challenges and building a healthier, more resilient world. We believe in growing through every challenge, continually striving to improve, and welcoming new perspectives that strengthen our community. We recognize that a vibrant and innovative organization values both individual strengths and shared purpose. The best ideas often emerge when people with different experiences come together.

As you consider joining UC Davis, we invite you to explore our Principles of Community, our Clinical Strategic Plan, and strategic vision for research and education. We believe you belong here. The University of California, Davis is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age or protected veteran status.

To view the University of California's Anti-Discrimination Policy, please visit: https://policy.ucop.edu/doc/1001004/Anti-Discrimination

Because we want you to feel seen and valued, our recruitment process at UC Davis supports openness and authenticity. Research shows that some individuals hesitate to apply unless they meet every qualification. You may be an excellent fit for this role-or the next one. We encourage you to apply even if your experience doesn't match every listed requirement. #YouBelongHere #CA-SB

To learn more about our background check program, please visit: https://hr.ucdavis.edu/departments/recruitment/ucd/selection/background-checks