Clinical Data Lead — EDC, CRF Design & CRO Liaison

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 110,000 - 120,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Clinical Data Manager to oversee data management activities for assigned studies, coordinating with Clinical Operations, Safety, Biostatistics, and CROs. The role will focus on ensuring data quality, timely delivery, and compliant documentation.

The position supports various data systems (EDC/IRT/ePRO) and requires experience in CRF design, DM plans, and TMF filing, with strong communication and organizational skills.

Qualifications

• Minimum of 2 years of experience in Clinical Data Management, with >3 years in a clinical data manager role preferred

Responsibilities

• Oversee CRO Data Management counterparts for assigned studies
• Provide status updates on DM study responsibilities to internal team, including metrics and deliverables progress
• Ensure development of high-quality study documentation from CROs (DMP, data handling, QC, archival)
• Facilitate filing of study DM documents in sponsor TMF
• Establish design of Case Report Forms (CRF) and CRF Completion Guidelines (CCG) to meet protocol requirements
• Manage development and maintenance of data entry systems (EDC, IRT, ePRO)
• Develop data review strategies and checks for assigned studies
• Coordinate timely data transfers and Data Transfer Agreements (DTAs)
• Monitor data review processes to ensure timely and proficient data review
• Collaborate across Clinical Operations, Clinical Safety, Biostatistics and CROs/vendors
• Identify and communicate risk to DM timelines; escalate where needed
• Adhere to internal standards and regulatory requirements (ICH, GxP, CDISC, 21 CFR 11)
• Other duties as required

Skills

Microsoft Office

Analytical skills

Verbal and written communication

Interpersonal skills

Attention to detail

Self-motivated

Education

Bachelor's degree or higher in medical or scientific field

Tools

EDC

IRT

ePRO

TMF platforms

Job description

Viking Therapeutics, Inc. is seeking a Clinical Data Manager to oversee data management activities for assigned studies, coordinating with Clinical Operations, Safety, Biostatistics, and CROs. The role will focus on ensuring data quality, timely delivery, and compliant documentation.

The position supports various data systems (EDC/IRT/ePRO) and requires experience in CRF design, DM plans, and TMF filing, with strong communication and organizational skills.