Clinical Data Manager - Team Lead

Clinical Data Manager -Supervisor

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 Supervisor and will report directly to the Data Management Program Manager. Incumbent will be responsible for overseeing the day-to-day tasks of the Data Managers 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 Analyst 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
• Responsible for supervising a team of Clinical Data Manager including hiring, training, mentorship, & performance management
• 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 five (5) years of on hands Clinical Data Management experience preferred
• Previous supervisory experience preferred
• R experience preferred but not required
• GitHub knowledge preferred 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
• Strong interpersonal and communication skills
• Outstanding organizational and time-management skills with the ability to prioritize tasks

Location: San Diego, CA

“The annual base salary range for this position is $78,540.17 - $97,529.62. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.”

Minimum Education: Bachelor's degree Minimum Experience: 1 year Minimum Field of Expertise: Proficient PC skills. Working knowledge of databases, spreadsheets, word processing and statistical software programs. Knowledge of business statistics and data analyses techniques. Ability to manage and analyze data. Strong analytical thinking and problem solving skills.