Business Data Analyst

University of Southern California•San Diego, CA

2d•$84,855•Hybrid

About The Position

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 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 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. 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 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

Bachelor’s Degree in Science, Technology, Engineering, or Medicine (STEM) required.
Minimum of four (4) years of on hands Clinical Data Management experience required.
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.

Nice To Haves

Master’s Degree in STEM preferred.
R, Python experience preferred.
Copilot, ChatGPT, Claude experience preferred.
GitHub knowledge preferred.

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.
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 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.