Clinical Data Manager
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: 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
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.
- Knowledge of database-related tools (e.g., SQLite, MySQL) is preferred
- Adherence to ATRI Clinical Data Management Standards.
Nice To Haves
- R experience preferred but not required
- GitHub knowledge preferred not required
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
