Clinical Data Associate II – Data Management & EDC

Viking Therapeutics; San Diego (CA); On-site; USD 75,000 - 90,000; Full time

Job summary

Viking Therapeutics is seeking a Clinical Data Associate II or Senior Clinical Data Associate to contribute to the performance of Clinical Data Management activities for assigned studies, following protocols, SOPs, and industry standards.

You will support data management tasks under the direction of the Clinical Data Manager, participate in CRF design reviews, assist with EDC/IRT/ePRO testing and maintenance, and help with data checks, query resolution, and data listings to ensure clean,

Qualifications

• Minimum of 1 year in Clinical Data Management (2+ years preferred).
• Bachelor’s degree or higher in a medical or scientific field.
• Strong verbal and written communication skills.
• Experience with clinical data entry system design, development, and maintenance (preferred).
• Experience performing data review plans (preferred).

Responsibilities

• Support Clinical Data Management activities for assigned clinical studies under the direction of the Clinical Data Manager.
• Review, maintain, and file study Data Management documentation.
• Participate in design review of CRF and CRF Completion Guidelines to align with protocol requirements.
• Assist with testing and maintenance of clinical data systems, including EDC, IRT, and ePRO.
• Perform data review activities under the guidance of the Clinical Data Manager, including data checks, query review, and issues tracking.
• Prepare data listings and metrics under the guidance of the Clinical Data Manager.
• Assist with data transfers and reconciliation activities in accordance with procedures.
• Collaborate with cross-functional team members to support study activities.
• Track activities and elevate data issues, risks, or delays to the Clinical Data Manager.
• Adhere to ICH, GxP, CDISC standards, and 21 CFR Part 11.
• Other duties as required.

Skills

Microsoft Office Suite

Analytical skills

Verbal and written communication

Self-motivated

Attention to detail

Education

Bachelor's degree or higher in a medical or scientific field

Tools

EDC systems

IRT

ePRO

Job description

Viking Therapeutics is seeking a Clinical Data Associate II or Senior Clinical Data Associate to contribute to the performance of Clinical Data Management activities for assigned studies, following protocols, SOPs, and industry standards.

You will support data management tasks under the direction of the Clinical Data Manager, participate in CRF design reviews, assist with EDC/IRT/ePRO testing and maintenance, and help with data checks, query resolution, and data listings to ensure clean,