University of Southern California
Clinical Data Manager
University of Southern California, San Diego, California, United States, 92189
The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials.
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, Advanced 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/specifications, 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 partner 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.
Participates 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.
Requirements
Bachelor’s Degree.
Minimum of two (2) years of hands‑on Clinical Data Management experience preferred.
R experience and GitHub knowledge preferred but not required.
Excellent analytical and problem‑solving skills.
Experience with Electronic Data Capture (EDC) systems.
Proficiency in MS Office, including Word, Excel, and PowerPoint, required.
Knowledge of database‑related tools (e.g., SQLite, MySQL) preferred.
Experience with AI tools (ChatGPT, Copilot, etc.) preferred.
R, R Studio, Python programming experience preferred.
Adherence to ATRI Clinical Data Management Standards.
Hybrid work schedule with a requirement of at least three days on‑site per week.
The hourly rate range for this position is $42.65 – $54.39 per hour. The University of Southern California determines compensation based on the scope and responsibilities of the position, the candidate’s experience and education, key skills, internal equity, and external market factors.
#J-18808-Ljbffr
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, Advanced 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/specifications, 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 partner 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.
Participates 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.
Requirements
Bachelor’s Degree.
Minimum of two (2) years of hands‑on Clinical Data Management experience preferred.
R experience and GitHub knowledge preferred but not required.
Excellent analytical and problem‑solving skills.
Experience with Electronic Data Capture (EDC) systems.
Proficiency in MS Office, including Word, Excel, and PowerPoint, required.
Knowledge of database‑related tools (e.g., SQLite, MySQL) preferred.
Experience with AI tools (ChatGPT, Copilot, etc.) preferred.
R, R Studio, Python programming experience preferred.
Adherence to ATRI Clinical Data Management Standards.
Hybrid work schedule with a requirement of at least three days on‑site per week.
The hourly rate range for this position is $42.65 – $54.39 per hour. The University of Southern California determines compensation based on the scope and responsibilities of the position, the candidate’s experience and education, key skills, internal equity, and external market factors.
#J-18808-Ljbffr