Clinical Data Associate II
Viking Therapeutics, Inc.•San Diego, CA
•$75,000 - $90,000
About The Position
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.
Requirements
- Minimum of 1 years of experience in Clinical Data Management
- Bachelor's degree or higher in a medical or scientific field
- Experienced verbal and written communication 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
Nice To Haves
- Experienced in clinical data entry system design, development, and maintenance
- Experienced in carrying out data review plans
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
