Strategic Clinical Data Manager - Trials & Data Quality

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 and ensure compliance with protocols, SOPs, and regulatory guidelines.

The role interacts with Clinical Operations, Safety, Biostatistics, and CROs to drive data quality and timely database lock. The position may involve designing CRFs, managing EDC/IRT/ePRO systems, and coordinating data transfers while adhering to CDISC, ICH, and FDA standards.

Qualifications

• Bachelor's degree or higher in a medical or scientific field.
• Minimum 2 years of Clinical Data Management experience.
• Experience with clinical data entry system design and maintenance.
• Strong written and verbal communication skills.
• Preferred: Experience in Phase 3 clinical trials.

Responsibilities

• Oversee CRO Data Management counterparts for assigned studies.
• Provide status updates on Data Management responsibilities to internal team, including metrics and deliverables.
• Ensure the development of high-quality study documentation from CROs for clinical trial data collection, handling, processing, quality control, and archival, including Data Management Plans (DMP).
• Facilitate filing of study Data Management documents in the sponsor Trial Master File (TMF).
• Establish optimal design of Case Report Forms (CRF) and corresponding CRF Completion Guidelines (CCG).
• Manage the development and maintenance of data entry systems for clinical trials, including EDC, IRT, and ePRO.
• Develop data review strategies, processes, and checks for assigned studies.
• Coordinate timely data transfers including Data Transfer Agreements (DTAs).
• Monitor and contribute to data review processes to verify timely data review.
• Partner with study team members in managing pre-lock activities and ensuring on-time database lock.
• Collaborate across Clinical Operations, Clinical Safety, and Biostatistics, internally and with CROs/vendors.
• Identify and communicate risk to Data Management timelines; escalate as needed and propose solutions.
• Adhere to ICH, GxP, CDISC, 21 CFR Part 11, FDA guidelines; other duties as required.

Skills

Data management

Documentation

Stakeholder communication

Problem solving

Education

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

Tools

EDC systems

DTA processes

Job description

Viking Therapeutics, Inc. is seeking a Clinical Data Manager to oversee data management activities for assigned studies and ensure compliance with protocols, SOPs, and regulatory guidelines.

The role interacts with Clinical Operations, Safety, Biostatistics, and CROs to drive data quality and timely database lock. The position may involve designing CRFs, managing EDC/IRT/ePRO systems, and coordinating data transfers while adhering to CDISC, ICH, and FDA standards.