CLINICAL DATABASE ANALYST in Chaska, Minnesota at Beckman Coulter Diagnostics

Date Posted: 8/9/2019

Job Snapshot

Job Description

Job ID: BEC015662

About Us

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.
Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.


Description

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.

Job Requirements



Qualifications

  • 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.
  • CDISC knowledge.
  • 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.


Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.