Clinical Data Manager

1w1 week ago

University of Southern California

San Diego, US · Full-time · $84,000 – $108,000

About this role

The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI) advances Alzheimer’s Disease treatments through innovative clinical trials. This Clinical Data Manager reports directly to the Data Management Program Manager. The role performs day-to-day tasks in database development and management.

Execute database activities including CRF Specifications, Data Validation Plans, Edit Check Specifications, and User Acceptance Testing. Drive UAT for clinical trial database builds and modifications. Coordinate with clinical data programmers on Post-Entry Checks, Advance Quality Checks, EDC actions, and Edit Checks.

Manage External Data Service Providers for data management and EDC like Central Lab, IRT, Biomarkers, and ECG. Provide directions to Data Associates on query issuance to sites. Escalate study issues and communicate with management and other functions while working with cross-functional teams on query resolutions.

Author and maintain study documentation such as Data Management Plans, Data Transfer Agreements, and CRF Data Entry Manuals. Identify risks, troubleshoot problems using metrics and audits, and propose process improvements. Participate in SOP development, regulatory inspections, and investigator meetings.

Requirements

Bachelor’s Degree
Minimum of two (2) years of hands-on Clinical Data Management experience preferred
Experience with Electronic Data Capture (EDC) systems
Proficiency in MS Office, including Word, Excel, and PowerPoint
Excellent analytical and problem-solving skills
R, R Studio, Python programming experience preferred
Knowledge of database-related tools (e.g., SQLite, MySQL) preferred
Experience with AI tools (ChatGPT, Copilot, etc.)

Responsibilities

Executes database development and management including CRF Specifications, Data validation plan, Edit Check Specifications, and User Acceptance Testing
Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications
Authors and maintains essential study documentation such as the Data Management Plans, Data Transfer Agreements/specifications, CRF Data Entry Manual
Manages External Data Service Provider contracted to perform data management and EDC activities such as the Central Lab, IRT, Biomarkers, ECG
Coordinates with the clinical data programmer during development of Post-Entry Checks, Advance Quality Checks, EDC actions, and Edit Checks
Provides directions to the Data Associate regarding query issuance to sites
Identifies risks and mitigation actions for data management related deliverables
Participates in development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities