Clinical Data Manager

University of Southern California•San Diego, CA

27d•$43 - $54•Hybrid

About The Position

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. This position will serve as a Clinical Data Manager and will report directly to the Data Management, Program Manager. Incumbent will be responsible for performing the day-to-day tasks of the Data Manager including but not limited to:

Requirements

Bachelor's Degree
Minimum of two (2) years of on hands Clinical Data Management experience preferred
Excellent analytical and problem-solving skills
Experience with Electronic Data Capture (EDC) systems
Proficiency in MS Office, including Word, Excel, and PowerPoint, required
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.
Experience in clinical trials data management.
Requires strong attention to detail with prior data entry experience.
Understands medical terms and familiar with various assessment criteria.
Strong verbal and written communication skills.
Able to manage time efficiently.

Nice To Haves

R experience preferred but not required
GitHub knowledge preferred not required
Knowledge of database-related tools (e.g., SQLite, MySQL) is preferred
Experience with AI tools (ChatGPT, Copilot, etc.)
R, R Studio, Python programming experience preferred

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