University of Southern California · 30 minutes ago
Clinical Data Manager
San Diego, CA
Full-time
Hybrid
Entry, Mid Level
$42.65/hr - $54.39/hr
2+ years expThe University of Southern California's Keck School of Medicine is seeking a Clinical Data Manager to support the Alzheimer Therapeutic Research Institute in San Diego, California. The role involves managing clinical trial data, executing database development, and collaborating with cross-functional teams to enhance data quality and operational efficiency.
EducationHigher EducationUniversities
Responsibilities
Executes database development and management (e.g., CRF Specifications, Data validation plan, Edit Check Specifications, User Acceptance Testing)
Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications
Escalates study-related issues and communicates as appropriate with management and other functions
Provides feedback on draft protocols and study-related documents as required
Coordinates with the clinical data programmer during the development of the Post-Entry Checks, Advance Quality Checks, EDC actions, and Edit Checks
Provides directions to the Data Associate regarding query issuance to sites
Authors and maintains essential study documentation such as the Data Management Plans, Data Transfer Agreements/specification, CRF Data Entry Manual)
Provides study updates at the Internal and Executive calls
Manages External Data Service Provider contracted to perform data management and EDC activities such as the Central Lab, IRT, Biomarkers, ECG
Assists with regulatory and Pharma/Biotech partners inspection activities
Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members
Works closely with the reporting team to build specifications for listings and report generations
Coordinates with cross-functional team members for query resolutions such as the serious adverse event
Presents at investigator’s meetings and helps lead data management training
Proposes process improvements and departmental initiatives
Identifies risks and mitigation actions for data management related deliverables
Maintains a broad understanding of current processes and methods as well as trends and directions of clinical data management and data analysis and reporting fields
Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
Coordinates with the eTMF team to file study documentation
Performs other duties as assigned
Qualification
Required
Bachelor's Degree
Excellent analytical and problem-solving skills
Experience with Electronic Data Capture (EDC) systems
Proficiency in MS Office, including Word, Excel, and PowerPoint
Excellent Analytical and Problem-solving skills: The ability to analyze complex data, identify patterns, attention to detail and develop solutions to data quality issues in a timely manner
Communication and Collaboration: Excellent written and verbal communication skills to effectively communicate and present data quality issues and solutions
Adherence to ATRI Clinical Data Management Standards
Hybrid work schedule with a requirement of at least three days on-site per week
Preferred
Minimum of two (2) years of on hands Clinical Data Management experience
R experience
GitHub knowledge
Knowledge of database-related tools (e.g., SQLite, MySQL)
Experience with AI tools (ChatGPT, Copilot, etc.)
R, R Studio, Python programming experience
Company
University of Southern California
University of Southern California is a private research university offering opportunities for interdisciplinary study and collaboration.
10001+ employees
H1B Sponsorship
University of Southern California has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (253)
2024 (239)
2023 (172)
2022 (207)
2021 (182)
2020 (195)
Funding
Current Stage
Late StageTotal Funding
$19.64MKey Investors
Patient-Centered Outcomes Research InstituteCalifornia Institute for Regenerative MedicineCDA Foundation
2025-02-04Grant· $10.8M
2025-01-30Grant· $5.93M
2024-07-30Grant
Leadership Team
David A Barnhart
Director, USC Space Engineering Research Center
H
Hossein Pourmand
Assistant Vice President, Research Initiatives, University Advancement
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