Business Data Analyst

The USC Keck School of Medicine Alzheimers 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 Alzheimers disease through innovative clinical trials.

This position serves as the Senior Clinical Data Manager and reports directly to the Clinical Data Management Program Manager. The incumbent is responsible for overseeing assigned studies and the related datamanagement team resources including but not limited to the following responsibilities:

• Leads performs and oversees datamanagement activities for assigned Alzheimers disease and related dementias (AD/ADRD) clinical studies supporting both inhouse and outsourced trial data. Evaluates develops and implements datamanagement 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 highquality 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 doseescalation and safety objectives.
• Demonstrated experience leading the development and management of AD/ADRD clinicaltrial databases that support complex trial designs and processes including adaptive randomization (CAR RAR BAR) platform trials decentralized trial models biomarkerinformed screening and enrollment and communitybased prescreening.
• Handson experience overseeing datamanagement workflows for AD/ADRD studies with particular focus on accelerated data cleaning continuous safetydata surveillance and timely execution of recurrent analyses.
• Works closely with Clinical Project Management Clinical Operations Safety Biostatistics and Informatics teams to enable timely decisionmaking and studygovernance processes in AD/ADRD trials.
• Performs handson clinical datamanagement activities to support clinical studies including reviewing study protocols designing eCRFs coordinating and executing useracceptance testing (UAT) developing and documenting editcheck specifications qualitycontrolling external data transfers conducting dataquality checks and discrepancy review and ensuring timely completion of databaselock activities.
• Participates in reviews and leads the development of policies Standard Operating Procedures (SOPs) processes and related documentation for datamanagement activities; provides input on SOPs and processes involving data management.
• Promotes and advocates for datamanagement practices in crossfunctional and departmental meetings.
• Provides domainspecific technical guidance to personnel in Data Management Biostatistics Informatics and other functions and leads the development and execution of both general and projectspecific 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 datamanagement practices and procedures including identifying proposing and implementing solutions for technologyrelated issues.
• Assists in developing standardized datamanagement documents across studies and programs including eCRFs and editcheck 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 programmers 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.
• Enthusiasm for working in a hybrid schedule (at least 60 percent onsite) and for interacting with stakeholders and peers in person.
• Perform other duties as assigned.

REQUIREMENTS:

• Bachelors Degree in Science Technology Engineering or Medicine (STEM) required.
• Masters Degree in STEM preferred.
• Minimum of four (4) years of on hands Clinical Data Management experience 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 $84855.38 - $. 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 candidates 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.

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 theBackground Screening Policy Appendix Dfor 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 or by email at. Inquiries will be treated as confidential to the extent permitted by law.

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