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 Alzheimerâs Disease (AD) through innovative clinical trials. Throughout our Institute the study teams are highly collaborative and are comprised of the lead scientist, ATRI faculty, biostatisticians, data managers, project managers, regulatory, system developers and industry partners.
We are looking to add a Clinical Research Data Manager to lead two to three studies (both intervention and non-intervention), performing and managing all aspects of the Clinical Data Management (CDM) role.
The successful candidate will have at least 2 yearsâ experience in clinical trials at a pharmaceutical, biotechnology, or academic clinical research institute: as well as a good understanding of databases and data analysis.
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 investigatorâs meetings and helps lead data management training
Proposes process improvements and departmental initiatives
Coordinate with the eTMF team to file study documentation
Performs other duties as assigned
Minimum of two(2) years of on hands Clinical Data Management 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
Outstanding organizational and time-management skills with the ability to prioritize tasks
Location:Â San Diego, CA
Salary is dependent on experience and education.
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum educationMinimum Experience: 2 yearsMinimum Field of Expertise: 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.
USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations. As the largest private employer in Los Angeles, responsible for $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.