Clinical Data Analyst

Edwards Lifesciences•Irvine, CA

15h•Hybrid

About The Position

The main function of a clinical data analyst is to lead and support clinical data management activities during study start-up, conduct and closeout, including database lock.

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.
Good written and verbal communication skills and interpersonal relationship skills.
Good problem-solving and critical thinking skills.

Nice To Haves

Experience using AI tools like Copilot and Claude to support clinical trial activities is preferred.

Responsibilities

Define and specify clinically data collection requirements (e.g., eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, using Global Library standards and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
Evaluate data errors and collection issues; provide guidance and recommendations to clinical team for resolution.
Lead project management activities for clinical studies online, 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.
Experience with Trial Master File (TMF) for clinical trial documentation and filing.
Participate in review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.