Clinical Data Associate II

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.

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 escalate 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

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

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, 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.

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.

$75,000.00 - $90,000.00 annual salary