Clinical Data Manager

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Viking Therapeutics, Inc. seeks a Clinical Data Manager to oversee CRO data management for studies, ensure timely data handling and archival, and lead CRF design aligned with trial protocols.

The role interfaces with Clinical Operations, Biostatistics, Safety, and CROs, and progresses toward data governance and regulatory compliance. The position requires 2+ years in clinical data management, a medical or scientific degree, and experience creating data management plans and specifications.

Qualifications

• Bachelor's degree or higher in a medical or scientific field.
• Experience writing plans and technical specifications for Clinical Data Management.
• Experience in clinical data entry system design, development, and maintenance.
• Experience in data review plans.
• Experience managing multiple projects.

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 design of Case Report Forms (CRF) and CRF Completion Guidelines (CCG) to align with protocol requirements and datasets for analysis.
• Manage development and maintenance of data entry systems for clinical trials (EDC/IRT/ePRO).
• Develop data review strategies and checks for assigned studies.
• Coordinate timely data transfers including Data Transfer Agreements (DTAs).
• Monitor data review processes to ensure timely, proficient review.
• Collaborate with study team in completing pre-lock activities and on-time database lock.
• Identify and communicate risk to Data Management and propose solutions.
• Adhere to ICH, GxP, CDISC, 21 CFR Part 11, FDA guidelines.

Skills

Analytical skills

Problem-solving

Verbal and written communication

Interpersonal skills

Microsoft Office proficiency

Education

Bachelor's degree or higher in medical or scientific field

Tools

Electronic Data Capture (EDC)

Interactive Response Technology (IRT)

Electronic Patient-Reported Outcomes (ePRO)

Job description

Viking Therapeutics is a clinical-stage biotechnology company advancing a next-generation portfolio of therapies for obesity and metabolic disease. We are developing treatments to help patients achieve meaningful, lasting improvements in health by treating obesity first. Our therapies are designed to support the long-term health benefits of weight loss, including cardiovascular health, improved physical function, and quality of life.

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 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.

Essential Duties and Responsibilities

The main responsibilities of this role include but are not limited to the following:

• 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

Requirements

Education and Experience

• Minimum of 2 years of experience in Clinical Data Management (>3 years experience with .2 years in Clinical Data Manager role preferred)
• Bachelor's degree or higher in a medical or scientific field
• Experienced verbal and written communication skills, including experience writing plans and technical specifications for Clinical Data Management
• Experienced in clinical data entry system design, development, and maintenance
• Experienced in carrying out data review plans
• Experienced in managing multiple projects at once
• Experienced identifying issues and applying insightful problem-solving to propose solutions
• Preferred: Experience in Phase 3 clinical trials

Knowledge and Skills

• High degree of proficiency Microsoft Office Suite, file sharing software, and online conferencing applications
• Strong analytical and problem-solving skills
• Strong verbal and written communication skills
• Excellent professional interpersonal skills with the ability to work in a positive and collaborative fashion
• Ability to manage multiple tasks at once and maintain strong attention to detail
• Self-motivated, dependable individual with self-confidence and a positive attitude