Viking Therapeutics, Inc. · 16 hours ago
Posting Clinical Data Manager I – Sr. Clinical Data Manager
San Diego, CA
Full-time
Onsite
Entry, Mid, Senior LevelViking Therapeutics, Inc. is a company dedicated to equal opportunity in employment. They are seeking a Senior Clinical Data Manager to oversee Clinical Data Management activities for assigned studies, ensuring compliance with protocols and regulations while collaborating with cross-functional teams.
Health CareMedicalTherapeutics
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
Qualification
Required
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
Company
Viking Therapeutics, Inc.
Viking Therapeutics, Inc.
Founded in 2012
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.06B2024-02-28Post Ipo Equity· $632.5M
2023-03-29Post Ipo Equity· $250M
2018-06-12Post Ipo Equity· $140.9M
Leadership Team
N
Neil Aubuchon
Chief Commercial Officer (CCO)
Recent News
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