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Staff Clinical Studies Scientist in Chaska, Minnesota at Beckman Coulter Diagnostics

Date Posted: 5/12/2019

Job Snapshot

Job Description

Job ID: BEC014290

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

The Staff Clinical Studies Scientist  (Study Lead) is responsible for the design, organization and conduct of complex internal and external clinical studies within the pre- and post-market phases for product. You will lead the full clinical study process from developing a comprehensive global clinical evidence plan to the clinical study report and site close-out visits, while following GCP, FDA and OUS requirements. The ideal candidate is experienced in the field of in vitro diagnostics and understands the laboratory environment as well as the basic product development process. 

Responsibilities may include, but are not limited to:
* Representing the clinical function on product development core teams
* Developing a comprehensive clinical plan to align with the project’s planned commercialization strategy
* Negotiating with FDA in collaboration with regulatory core team member
* Designing and writing essential clinical documents, including study protocols, monitoring plans, eCRFs, study reports, etc…
* Identifying, contacting and qualifying potential investigators
* Negotiating study contracts, budgets and financial payments
* Providing indirect work direction and mentoring to developing clinical study scientists
* Perform clinical study monitoring activities consistent with GCP
* Collaborate with biostatisticians and data management team members
* Reviewing the stats analysis of the clinical data and summarizing into required study reports
* Manage any contract personnel supporting clinical deliverables
* Support responses to regulatory bodies for clinical questions
* Facilitate publication of clinical data in professional journals and company literature
* Provide concise and effective updates to clinical management to support business unit initiatives

Job Requirements



Qualifications

Qualifications:
* Bachelor’s degree with 9+ years’ experience, Master’s with 7+ years’ experience, or Doctoral degree with 4+ years
* Experience designing, organizing and conducting complex clinical trials
* Experience in review of statistical analysis of clinical data, writing summary reports and technical articles for publication in professional journals
* Experience in IVD product development (preferred)
* Experience with cardiac, hepatic, thyroid, reproductive disease / studies (preferred)
* Experience with planning, designing, and executing adjudication process
* Familiarity with data management concepts
* Stays current with disease states and therapeutic approaches
* Must be detail-oriented; demonstrate excellent verbal/written communication skills and interpersonal skills.
* Travel is approx 35%

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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.