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Business Data Analyst, Senior

University of Southern California

San Diego, CA

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JOB DETAILS
SALARY
$113,939.96–$152,210.32 Per Year
LOCATION
San Diego, CA
POSTED
7 days ago
The USC Keck School of Medicine Alzheimer’s Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic research institute composed of a multidisciplinary team of scientific collaborators dedicated to advancing the development of novel diagnostics and therapies for Alzheimer’s disease through innovative clinical trials. This position serves as the Principal Clinical Data Manager and reports directly to the Clinical Data Management Program Manager. The incumbent is responsible for overseeing assigned studies and the related data‑management team resources, including but not limited to the following responsibilities: Leads, performs, and oversees data‑management activities for assigned Alzheimer’s disease and related dementias (AD/ADRD) clinical studies, supporting both in‑house and outsourced trial data. Evaluates, develops, and implements data‑management processes, procedures, and tools to meet evolving business and regulatory requirements. Collaborates closely with Biostatistics, Informatics, Clinical Project Management, Clinical Operations, Medical, Drug Safety/Pharmacovigilance (DSPV), Regulatory, Project Management, and other internal stakeholders to ensure delivery of high‑quality data for regulatory submissions, safety reporting, and scientific publications. Demonstrated experience leading and supporting AD/ADRD clinical studies, including early protocol review, eCRF and database design, and alignment with dose‑escalation and safety objectives. Demonstrated experience leading the development and management of AD/ADRD clinical‑trial databases that support complex trial designs and processes, including adaptive randomization (CAR, RAR, BAR), platform trials, decentralized trial models, biomarker‑informed screening and enrollment, and community‑based prescreening. Extensive hands‑on experience overseeing data‑management workflows for AD/ADRD studies, with particular focus on accelerated data cleaning, continuous safety‑data surveillance, and timely execution of recurrent analyses. Works closely with Clinical Project Management, Clinical Operations, Safety, Biostatistics, and Informatics teams to enable timely decision‑making and study‑governance processes in AD/ADRD trials. Performs hands‑on clinical data‑management activities to support clinical studies, including reviewing study protocols, designing eCRFs, coordinating and executing user‑acceptance testing (UAT), developing and documenting edit‑check specifications, quality‑controlling external data transfers, conducting data‑quality checks and discrepancy review, and ensuring timely completion of database‑lock activities. Participates in, reviews, and leads the development of policies, Standard Operating Procedures (SOPs), processes, and related documentation for data‑management activities; provides input on SOPs and processes involving data management. Promotes and advocates for data‑management practices in cross‑functional and departmental meetings. Provides domain‑specific technical guidance to personnel in Data Management, Biostatistics, Informatics and other functions, and leads the development and execution of both general and project‑specific training initiatives. Assists in responding to questions and findings from QA audits and ensures that Corrective Action Forms (CAFs) are addressed and closed out appropriately. Actively monitors and researches current industry trends in clinical data management and shares relevant insights with appropriate stakeholders. Recommends enhancements to existing data‑management practices and procedures, including identifying, proposing, and implementing solutions for technology‑related issues. Assists in developing standardized data‑management documents across studies and programs, including eCRFs and edit‑check specifications. Participate in selecting outsourcing vendors and review data management sections of proposals, including scope of work; monitor budgets as appropriate. Coordinate data management timelines for individual projects and well as clinical programs, including database lock, DSMB meetings, data review meetings, and monitoring CRO performance of data management tasks to ensure that timelines are met and that any resource issues are identified and resolved. Monitor in-house clinical data management resources of assigned projects and identify potential deficiencies; work with supervisor to develop and implement a plan to overcome any obstacles. Ensure that appropriate quality control checks and audit procedures are implemented according to department SOPs. Run data review listings, issue queries, ensure medical coding is timely. Collaborate with database programmer to ensure ATRI data standards, including CDISC/SDTM, are followed for both in-house and, if appropriate, outsourced projects. Identify areas of risk and proactively communicate issues and solutions to supervisor and/or appropriate colleagues and team members. Actively participate in data management-related NDA submission activities, as appropriate. Provide feedback, as requested, for performance evaluations. Identify strengths and areas for improvement for CDM team members and work with supervisor to create a plan to develop team members. Works to improve tools and processes within functional area. Ability to work as part of and lead multiple teams. Perform other duties as assigned. Enthusiasm for working in a hybrid schedule (at least 60 percent onsite) and for interacting with stakeholders and peers in person. REQUIREMENTS: Bachelor’s Degree in Science, Technology, Engineering, or Medicine (STEM) required. Master’s Degree in STEM preferred. Minimum of seven (7) years of on hands Clinical Data Management experience preferred. Previous experience in clinical data management required. R, Python experience preferred. Copilot, ChatGPT, Claude experience preferred. GitHub knowledge preferred. Excellent analytical and problem-solving skills. Experience with Electronic Data Capture (EDC) systems. Strong proficiency in Microsoft Office, including Word, Excel, and PowerPoint, required. Excellent interpersonal and communication skills. Outstanding organizational and time-management skills with the ability to prioritize tasks. The annual base salary range for this position is $113,939.96 - $152,210.32. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations. Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 3 years Minimum Skills: Direct knowledge and experience in data modeling, data warehousing and reporting. Project management experience for complex projects. Demonstrated organizational, critical thinking, interpersonal, planning, problem solving, and business analytical skills. Able to work at a high functional and technical level. Preferred Education: Bachelor's degree In Statistics Or Economics Or Mathematics Or Accounting Or Business Administration Or Computer Science Or Information Science Or Management Science Or in related field(s) Preferred Experience: 5 years Preferred Skills: Expert knowledge of Data Warehousing methods (e.g., Kimball) and Relational and Analytical data structures (e.g., RDBMS, OLAP). Impressive experience in designing managerial level presentations and reports. Outstanding skills in finding resolution to complicated problems while performing independently in a multifaceted environment. USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at (213) 821-8100, or by email at uschr@usc.edu. Inquiries will be treated as confidential to the extent permitted by law. Notice of Non-discrimination Employment Equity Read USC’s Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: https://wd5.myworkday.com/usc/d/inst/1$9925/9925$143544.htmld USC is a leading private research university located in the heart of downtown Los Angeles – a global center for arts, technology and international business. As the largest private employer in the city – responsible for more than $5 billion annually in economic activity in the region – we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills. As a USC employee, you will enjoy excellent benefits and perks, and you will be a member of the Trojan Family - the faculty, staff, students and alumni who make USC a great place to work. Application help If you need assistance during the application process, see our application help. (If you already work for USC, see Your USC career.) At any point you may also contact our HR Service Center for help at (213) 821-8100 or uschr@usc.edu. Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!

About the Company

U

University of Southern California