Clinical Data Management Analyst

Clinical Data Management Analyst

We are seeking a Clinical Data Management Analyst for a large medical technology company based in Irvine. This is a W2 hourly position with Roth Staffing, Ledgent Technology is a division of Roth Staffing. No third party candidates can be considered for this position.

Pay: $40.00 - $45.00/Hour

Summary: The main function of a clinical data analyst is to create moderately complex metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training and provide basic recommendations to improve data status during study conduct.

Key Responsibilities:

• Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
• Lead project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations (10%)
• Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access database
• Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.

Skills:

• Experience with EDC (Electronic Data Capture) systems required
• Good computer skills in Microsoft Office Suite
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills

Education and Experience:

• Bachelor's Degree or equivalent
• 2-4 years of experience required
• Medidata Rave experience required

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.