Posting Clinical Data Manager I – Sr. Clinical Data Manager

Viking Therapeutics, Inc. • San Diego, CA

3d

About The Position

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 the conduct of clinical trials. The Clinical Data Manager will interact internally and externally with cross-functional teams, including Clinical Operations, Clinical Safety, Biostatistics, and CROs. Exact title (Clinical Data Manager I, Clinical Data Manager II, or Senior Clinical Data Manager) will depend on experience and skill level.

Responsibilities

• Oversee CRO Data Management counterparts for assigned studies
• Provide status updates on Data Management study responsibilities to internal team, including metrics and progress on 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) to align with protocol requirements, meet trial oversight needs, and result in datasets suitable for analysis
• Manage the development and maintenance of data entry systems for clinical trials, including Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient-Reported Outcomes (ePRO)
• Develop data review strategies, processes, and specific checks for assigned studies
• Coordinate timely data transfers including development of Data Transfer Agreements (DTAs)
• Monitor and contribute to data review processes to verify that timely and proficient data review is being carried out
• Partner with study team members in managing the completion of pre-lock activities and ensuring on-time database lock
• Collaborate across functional areas including Clinical Operations, Clinical Safety, and Biostatistics, both internally and externally with CROs and vendors
• Identify and communicate risk to Data Management components of clinical trials; escalate risk to timelines as appropriate and provide insight and propose solutions
• Adhere to Clinical Data Management internal standards as well as industry standards and regulatory requirements, including ICH guidelines, Good Practice guidelines (GxP), CDISC standards, 21 CFR Part 11, and FDA guidelines
• Other duties as required

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed