Clinical Data Associate II

Viking Therapeutics; San Diego (CA); On-site; USD 75,000 - 90,000; Full time

Job summary

Viking Therapeutics is seeking a Clinical Data Associate II or Senior Clinical Data Associate to contribute to the performance of Clinical Data Management activities for assigned studies, following protocols, SOPs, and industry standards.

You will support data management tasks under the direction of the Clinical Data Manager, participate in CRF design reviews, assist with EDC/IRT/ePRO testing and maintenance, and help with data checks, query resolution, and data listings to ensure clean,

Qualifications

• Minimum of 1 year in Clinical Data Management (2+ years preferred).
• Bachelor’s degree or higher in a medical or scientific field.
• Strong verbal and written communication skills.
• Experience with clinical data entry system design, development, and maintenance (preferred).
• Experience performing data review plans (preferred).

Responsibilities

• Support Clinical Data Management activities for assigned clinical studies under the direction of the Clinical Data Manager.
• Review, maintain, and file study Data Management documentation.
• Participate in design review of CRF and CRF Completion Guidelines to align with protocol requirements.
• Assist with testing and maintenance of clinical data systems, including EDC, IRT, and ePRO.
• Perform data review activities under the guidance of the Clinical Data Manager, including data checks, query review, and issues tracking.
• Prepare data listings and metrics under the guidance of the Clinical Data Manager.
• Assist with data transfers and reconciliation activities in accordance with procedures.
• Collaborate with cross-functional team members to support study activities.
• Track activities and elevate data issues, risks, or delays to the Clinical Data Manager.
• Adhere to ICH, GxP, CDISC standards, and 21 CFR Part 11.
• Other duties as required.

Skills

Microsoft Office Suite

Analytical skills

Verbal and written communication

Self-motivated

Attention to detail

Education

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

Tools

EDC systems

IRT

ePRO

Job description

Description

The Clinical Data Associate will contribute to the performance of Clinical Data Management activities for assigned studies according to protocols, industry standards and guidelines, and Standard Operating Procedures (SOPs). Exact title (Clinical Data Associate II or Senior Clinical Data Associate) 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:

• Support Clinical Data Management activities for assigned clinical studies under the direction of the Clinical Data Manager
• Support the review, maintenance, and filing of study Data Management documentation
• Participate in design review of Case Report Forms (CRF) and corresponding CRF Completion Guidelines (CCG) to align with protocol requirements and data collection standards
• Assist with the testing and maintenance of clinical data systems, including Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient-Reported Outcomes (ePRO)
• Perform data review activities under the guidance of the Clinical Data Manager, including execution of data checks, query review, and issues tracking
• Prepare data listings and metrics under the guidance of the Clinical Data Manager
• Assist with data transfers and reconciliation activities in accordance with defined procedures
• Collaborate with cross-functional team members and external to support study activities as directed
• Track activities and elevate data issues, risks, or delays to the Clinical Data Manager as appropriate
• Adhere to Clinical Data Management internal standards and applicable regulatory and industry requirements, including ICH guidelines, Good Practice guidelines (GxP), CDISC standards, and 21 CFR Part 11
• Other duties as required

Requirements

Education and Experience

• Minimum of 1 years of experience in Clinical Data Management (>2 years preferred)
• Bachelor's degree or higher in a medical or scientific field
• Experienced verbal and written communication skills
• Preferred: Experienced in clinical data entry system design, development, and maintenance
• Preferred: Experienced in carrying out data review plans

Knowledge and Skills

• Proficient in 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

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Salary Description

$75,000.00 - $90,000.00 annual salary