Clinical Data Management Analyst II

Job Title: Clinical Data Management Analyst II

Pay Rate: $40 to $48.54/Hr

Duration: 12 Months

Location: Irvine, CA (Hybrid - 3 Days onsite, 2 days remote a Week)

Our Client is a Global medical device Manufacturer.

We are looking for a Clinical Data Management Analyst II





The primary responsibility of the Clinical Data Management Analyst II is to support
CDM study start‑up activities, including developing database specifications, authoring and executing test scripts, and preparing key CDM deliverables.


- 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 is collected.
- Maintain and develop assigned sections of Data Management deliverables, including
data management plans (DMPs), CRF completion guidelines, training materials, and user aids in compliance with regulations.
- Perform Site/User Administration, including generating and validating
EDC reports and Subject PDFs.
- Evaluate data errors and collection issues; provide guidance and recommendations to the clinical team for resolution
- Assist in leading project management activities for a cohort or project to bring clinical studies online, including conducting project team meetings, establishing and maintaining project timelines, and communicating with stakeholders.
- Participate in the development and 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.


Requirements:


- Bachelor's Degree or equivalent with 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.
- Experience with using AI tools like CoPilot, Claude to support clinical trial activities is preferred.