Kelly Services Clinical Data Analyst I in Chaska, Minnesota
Kelly is seeking a Clinical Data Analyst for one of our biotechnology clients in Chaska, MN.
Remote/On-Site: The position can be in Chaska or it can be remote.
Job Title: Clinical Data Analyst
Pay Rate: $47.35/hr
1 year contract
Clinical Data Analyst will provide technical and day-to-day application support for the Clinical Affair Organization. He/she will design, program, manage and document database projects and ensure process improvement and the promotion of new tools and techniques. This position is responsible for leveraging the Danaher Business System and tools in the timely and high-quality execution of a clinical data management strategy for pre-market and post-market trials.
Duties & Responsibilities:
Develop the data management plan for clinical studies.
Execute the data management plan throughout lifecycle of the study.
Participate in developing the case report form (CRF).
Develop database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
Develop data transfer agreement(s) between external data sources and/or labs.
Assist in database upgrades/migrations including performing user acceptance testing
Maintain/track of EDC user management and other clinical databases across allocated clinical trials, compile master user lists and activate/deactivate user accounts.
Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
Perform database lock and freeze activities.
Coordinate the archiving of study databases and related documents.
Perform close-out audits
Ensures data system compliance by following the established guidelines of regulatory authorities.
QUALIFICATIONS AND EXPERIENCE:
Bachelor’s degree in Computer Science, Mathematics, Statistics, Pharmaceuticals Sciences, Life Sciences or related fields and 3+ years’ experience.
Must have knowledge and experience with Medidata.
Capability of Medidata study building.
Project management and delegation skills.
Strong communication skills.
Knowledge and experience in developing study dataset specifications.
Previous work experience in a diagnostic, medical device or pharmaceutical.
Understanding of validation requirements for software tools in a plus.
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Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
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