Job Description: Job ID: BEC012018
At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates' careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.
We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.
Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences.
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.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.
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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
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.
Able to travel up to 70% of the time during execution of study
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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 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.