Clinical Data Analyst - 12-Month Contract, Data Quality

Ledgent Technology; Irvine (CA); On-site; USD 51,000 - 69,000; Full time

Job summary

Ledgent Technology in Irvine, CA seeks a Clinical Data Analyst for a 12-month W-2 contract to lead data management activities across the study lifecycle. You will ensure accurate data collection, data quality, and regulatory compliance while coordinating with clinical teams.

Responsibilities include defining data collection requirements, coordinating UAT, resolving data discrepancies, and maintaining DMPs and TMF documentation.

Qualifications

• Bachelor's Degree or equivalent combination of education and experience.
• 2 to 4 years of Clinical Data Management or Clinical Data Analyst experience.
• Experience with Electronic Data Capture (EDC) systems, including Medidata RAVE Classic and Medidata RAVE EDC (new platform).
• Experience supporting clinical trials and clinical study data management activities.
• Proficiency in Microsoft Office Suite.

Responsibilities

• Define and specify clinical data collection requirements, including eCRFs/CRFs, edit checks, and external data collection requirements.
• Coordinate User Acceptance Testing (UAT) using test scripts and checklists.
• Review, evaluate, and resolve data discrepancies and collection issues.
• Provide recommendations and guidance to clinical teams regarding data quality and issue resolution.
• Lead data management project activities: study meetings, timelines, and stakeholder communications.
• Develop and maintain Data Management documentation (DMPs, training materials, user guides).
• Ensure regulatory compliance and company procedures.
• Perform user access management and data reconciliation, TMF documentation and filing.
• Participate in SOP revisions and training initiatives.

Skills

CDM

EDC

Medidata RAVE Classic

Medidata RAVE EDC

UAT

TMF

SOP Documentation

Training

Education

Bachelor's Degree or equivalent

Tools

Medidata RAVE (Classic)

Medidata RAVE EDC (New)

Job description

Ledgent Technology in Irvine, CA seeks a Clinical Data Analyst for a 12-month W-2 contract to lead data management activities across the study lifecycle. You will ensure accurate data collection, data quality, and regulatory compliance while coordinating with clinical teams.

Responsibilities include defining data collection requirements, coordinating UAT, resolving data discrepancies, and maintaining DMPs and TMF documentation.