Clinical Data Analyst

Position: Sr Analyst, Clinical Data Management, Req#: 18401-1
Location: Irvine, CA (hybrid)
Duration: 18+ Months Contract with high possibility of extension/conversion

Preferred Qualifications:

• Local candidates are preferred, with a hybrid work schedule of 3 days on-site and 2 days remote/WFH.
• Qualified remote candidates within the U.S. can be considered.

Interview Process:

• Round 1: Hiring Manager screening interview.
• Round 2: Interview with the next-level leader.

Job Description:

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 the need for training and provide basic recommendations to improve data status during study conduct.

Education and Experience: 

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

Job Responsibilities: 

• Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution
• Define and specify clinical 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 the 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.

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