Clinical Data Manager
Viking Therapeutics, Inc.
August 10, 2026
Remote friendly (San Diego, CA)
United States
$110,000 - $120,000 USD yearly
Clinical Research and Development
Description
The Clinical Data Manager will ensure timely conduct of Clinical Data Management activities for assigned studies according to protocols, industry standards and guidelines, Standard Operating Procedures (SOPs), and all applicable regulations governing clinical trials. Interacts internally and externally with cross-functional teams (Clinical Operations, Clinical Safety, Biostatistics, and CROs). Exact title depends on experience and skill level.
Essential Duties and Responsibilities
- Oversee CRO Data Management counterparts for assigned studies
- Provide status updates on Data Management responsibilities (metrics and deliverable progress)
- Ensure high-quality study documentation from CROs (DMPs; data collection, handling, processing, quality control, archival)
- Facilitate filing of Data Management documents in the sponsor Trial Master File (TMF)
- Design Case Report Forms (CRF) and CRF Completion Guidelines (CCG) aligned to protocol requirements and analysis-ready datasets
- Manage clinical trial data entry systems (EDC, IRT, ePRO)
- Develop data review strategies, processes, and specific checks
- Coordinate timely data transfers, including Data Transfer Agreements (DTAs)
- Monitor/contribute to data review processes; support pre-lock activities and on-time database lock
- Collaborate across functional areas and with CROs/vendors
- Identify and communicate Data Management risks; escalate and propose solutions
- Adhere to standards/regulations (ICH, GxP, CDISC, 21 CFR Part 11, FDA guidelines)
Requirements
- Minimum 2 years Clinical Data Management (>3 years; >2 years in Clinical Data Manager role preferred)
- Bachelor’s degree or higher in medical/scientific field
- Experience writing plans and technical specifications; strong written/verbal communication
- Experience designing/developing/maintaining clinical data entry systems
- Experience executing data review plans; managing multiple projects
- Identify issues and problem-solve
- Preferred: Phase 3 clinical trial experience
Knowledge and Skills
- Proficiency in Microsoft Office Suite, file sharing, and online conferencing
- Strong analytical/problem-solving and interpersonal skills; attention to detail
- Self-motivated, dependable, positive attitude
The Clinical Data Manager will ensure timely conduct of Clinical Data Management activities for assigned studies according to protocols, industry standards and guidelines, Standard Operating Procedures (SOPs), and all applicable regulations governing clinical trials. Interacts internally and externally with cross-functional teams (Clinical Operations, Clinical Safety, Biostatistics, and CROs). Exact title depends on experience and skill level.
Essential Duties and Responsibilities
- Oversee CRO Data Management counterparts for assigned studies
- Provide status updates on Data Management responsibilities (metrics and deliverable progress)
- Ensure high-quality study documentation from CROs (DMPs; data collection, handling, processing, quality control, archival)
- Facilitate filing of Data Management documents in the sponsor Trial Master File (TMF)
- Design Case Report Forms (CRF) and CRF Completion Guidelines (CCG) aligned to protocol requirements and analysis-ready datasets
- Manage clinical trial data entry systems (EDC, IRT, ePRO)
- Develop data review strategies, processes, and specific checks
- Coordinate timely data transfers, including Data Transfer Agreements (DTAs)
- Monitor/contribute to data review processes; support pre-lock activities and on-time database lock
- Collaborate across functional areas and with CROs/vendors
- Identify and communicate Data Management risks; escalate and propose solutions
- Adhere to standards/regulations (ICH, GxP, CDISC, 21 CFR Part 11, FDA guidelines)
Requirements
- Minimum 2 years Clinical Data Management (>3 years; >2 years in Clinical Data Manager role preferred)
- Bachelor’s degree or higher in medical/scientific field
- Experience writing plans and technical specifications; strong written/verbal communication
- Experience designing/developing/maintaining clinical data entry systems
- Experience executing data review plans; managing multiple projects
- Identify issues and problem-solve
- Preferred: Phase 3 clinical trial experience
Knowledge and Skills
- Proficiency in Microsoft Office Suite, file sharing, and online conferencing
- Strong analytical/problem-solving and interpersonal skills; attention to detail
- Self-motivated, dependable, positive attitude