Clinical Data Management Analyst

Cynet Systems • Irvine, CA

1d

About The Position

The Clinical Data Management Analyst will be responsible for defining and specifying clinical data collection requirements, including eCRFs, CRFs, edit checks, and the collection of external data for assigned studies. This role involves defining, performing, and utilizing Global Library standards, and coordinating user acceptance testing to ensure appropriate data collection. The analyst will evaluate data errors and collection issues, providing guidance and recommendations to the clinical team for resolution. Additionally, the role includes leading project management activities for clinical studies, such as conducting project team meetings, maintaining project timelines, and communicating with stakeholders. The analyst will also maintain and develop Data Management deliverables, including Data Management Plans (DMPs), training materials, and user aids, in compliance with regulations. Performing User Access and data reconciliation (external and internal) is also a key responsibility. The role involves participating in the review of SOPs, work instructions, and associated documents for Clinical Data Management (CDM), recommending revisions and updates, and participating in the development of user training.

Requirements

• Bachelor's Degree or equivalent.
• 2-4 years of experience required.
• Experience with EDC (Electronic Data Capture) systems required, both Classic and New Medidata RAVE EDC.
• Good computer skills in Microsoft Office Suite.
• Experience with Trial Master File (TMF) for clinical trial documentation and filing.
• Medidata RAVE EDC.
• Microsoft Office Suite.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.
• Problem-solving and critical thinking skills.

Nice To Haves

• Experience with using AI tools like CoPilot or Claude to support clinical trial activities is preferred.
• AI tools (CoPilot, Claude).

Responsibilities

• Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies.
• Define, perform, and use Global Library standards and coordinate user acceptance testing to ensure appropriate data are collected.
• Evaluate data errors and collection issues and provide guidance and recommendations to clinical team for resolution.
• Lead project management activities for clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.
• Maintain and develop Data Management deliverables including data management plans (DMPs), training materials, and user aids in compliance with regulations.
• Perform User Access and data (external and internal) reconciliation.
• Participate in review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs and participating in the development of user training.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level