Clinical Research Data Manager

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.

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 years’ experience in clinical trials at a pharmaceutical, biotechnology, or academic clinical research institute: as well as a good understanding of databases and data analysis.

Key Responsibilities:

• Accountable for defining the data capture tools for a clinical study.
• Work closely with the scientific team to determine deliverables and study expectations.
• Coordinate with our team of data analysts and programmers to establish all aspects of data collection, data transfers, data cleaning, and reporting.
• Develop the Data Management Plan for the assigned study.
• Provide training on the EDC system and eCRF Data Entry Manual at Investigator Meetings and to internal and external collaborators as needed.
• Establish and document study-specific data handling processes for non-CRF data, including images and lab-data.
• Manage the in-stream data flow activities and deliver a quality database following the Data Management Plan.
• Develop and manage the execution of User Acceptance Testing (UAT) and including dataset definitions and external data sources.
• Coordinate database launch to database lock activities.
• Collaborate with vendor/3rd party regarding data collection and formatting.
• Contribute to continuous process improvement and process optimization initiatives.
• Contribute to cross-functional collaboration, decision-making, and goal setting.

Salary is dependent upon education and experience. Position is located in San Diego, CA.

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.