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Senior Manager Clinical Operations in Chaska, Minnesota at Beckman Coulter Diagnostics

Date Posted: 2/7/2019

Job Snapshot

Job Description

Job ID: BEC013993

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 Senior Manager Clinical Operations leads in the planning and execution of a portfolio of both pre-market and post-market clinical research programs for the Chemistry & Immunoassay business (Chaska, MN) while adhering to budget, scope and business timelines.  This position provides operational leadership to ensure timely completion of assigned clinical programs and cultivates the organization to provide staffing and support of sponsored clinical programs across the globe.  

The Sr. Manager collaborates across businesses and across regions as they lead efforts in planning and communication with cross-functional teams and external partners (investigators, contract laboratories, CRO/VCO staff) to ensure proper project planning and execution.  The Sr. Manager will ensure compliance to applicable regulatory requirements, industry standards, and company policies & SOPs.  

The primary responsibilities for the Sr. Manager Clinical Operations include:
  • Oversees clinical department’s operational infrastructure and staffing (in-house and contract/consultant) for a portfolio of assigned clinical programs with focus on understanding clinical evidence strategy, trial strategy, trial planning/execution/reporting/closeout, publication.
  • Leads team in executing targeted sponsor responsibilities (trial master file, site contracts/payments, monitoring (SQV, IMV, COV), study supplies/shipping) that are required to conduct and monitor clinical trials, ensuring that applicable policies, procedures and regulatory standards for Good Clinical Practice are followed. 
  • Ensures projects are resourced appropriately and that clinical associates are qualified and trained. Meets business needs through effective collaboration across programs located in multiple global regions and across operating companies.
  • Leverages knowledge and experience (within team, across functional lines) to solve complex problems and ensure that the development of clinical strategies and objectives for sponsored clinical programs achieve business goals.
  • Leads using Danaher Business System process/tools and clinical standard operating procedures to ensure timely completion of clinical trials within established budgets, industry standards of regulatory compliance and quality metrics with a focus on continuous process improvement.
  • Represents the operating company as a respected clinical trials expert including primary participation in industry consortia and regulatory agency meetings (region-based).
  • Performs other duties as assigned

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Job Requirements



Qualifications

  • Education: BS/BA, Masters’ degree preferred (green/black belt or PMP are highly preferred)
  • Preferred major: Biologic sciences
  • Experience: Candidates should have 14 years relevant work experience with BS degree, or 12 years experience with MS or PhD and 4 years experience in people management..  Prior demonstrated experience in the successful design/execution of premarket clinical research studies is highly preferred (as evidenced with a CCRA certification).  Prior demonstrated experience in building strong teams and mentoring others is highly preferred. Strong skills in MS Excel are highly preferred. 
  • Business travel:  Ability to travel (20-35% US and/or international), and participation in professional activities outside of normal business hours

TECHNICAL SKILLS:

A Bachelor’s degree (Master’s degree preferred) with >10 years of experience.  Demonstrable success in a managerial role is highly preferred.

The candidate must possess highly effective interpersonal skills enabling them to lead a team through negotiation, coaching and mentoring, have a strong understanding of clinical studies including GCP guidelines (ICHe6r2 or ISO14155) and applicable regulatory requirements, and display both flexibility and integrity. 

The ideal candidate should also be well organized and detail oriented, have strong written and verbal communication skills, be highly proficient in MS Office (Word, Excel, Powerpoint), and have the ability to multi-task and work effectively in a team or independently on assigned tasks.


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 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.