Clinical Data Manager at Keck USC Staffing LLC

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Mar, 26

Salary

54.39

Posted On

15 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Database Development, User Acceptance Testing, Data Validation, Electronic Data Capture, Analytical Skills, Problem-Solving, Communication, Collaboration, R Programming, Python Programming, MS Office, Data Quality, Regulatory Compliance, Process Improvement, SOP Development

Industry

Hospitals and Health Care

Description

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 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 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 Experience with AI tools (ChatGPT, Copilot, etc.) R, R Studio, Python programming experience preferred Adherence to ATRI Clinical Data Management Standards. Hybrid work schedule with a requirement of at least three days on-site per week. The hourly rate range for this position is $42.65 - $54.39. 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, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum 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 an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at (213) 821-8100, or by email at uschr@usc.edu. Inquiries will be treated as confidential to the extent permitted by law. 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Responsibilities

The Clinical Data Manager will execute database development and management tasks, drive User Acceptance Testing activities, and coordinate with cross-functional teams for query resolutions. They will also manage external data service providers and assist with regulatory inspection activities.