Manager, Global Clinical Compliance in Miami, Florida at Beckman Coulter Diagnostics

Date Posted: 7/5/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/5/2018

Job Description

Job ID: BEC011133

About Us

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. 


Description

This position is responsible for leveraging the Danaher Business System and tools in the development and execution of a clinical quality system that drives clinical process excellence as a source of competitive advantage. 

Develops and implements the Beckman Coulter clinical quality system (standard operating procedures, templates, guidance) and clinical audit programs (audit, CAPA) designed to increase associate awareness and knowledge of clinical compliance and business requirements related to sponsored clinical trials.


 Oversees activities required to maintain, measure compliance and monitor training affectivity of the clinical quality system as the designated Global Process Owner.

 Leverages knowledge and experience to ensure that clinical compliance objectives for sponsored clinical programs achieve business goals.

 Ensures timely completion of clinical trials within established budgets, timelines and quality metrics with a focus on continuous process improvement.

 Represents the operating company as a respected clinical compliance expert including primary participation in industry consortia and regulatory agency meetings.

 Collaborates with other operating companies, as appropriate.

Major Responsibilities:


• Accountable for costs, methods and associates (where appropriate) as defined by company policies and procedures.  Cultivates a positive work environment that reflects company values, embraces collaboration across functions and businesses and promotes associate development.

• Responsible for executing the company strategy for clinical affairs with focus on the oversight and administration of clinical policies, standard operating procedures, systems, tools and compliance metrics for Beckman Coulter and other operating companies (as applicable).  

  Responsible for close partnership and positive influence with business units, business groups, and regions to meet business needs with respect to clinical compliance.    

• Serves as a representative for Beckman Coulter or works with other company key contacts who participate in external working groups to influence changes in the global regulatory requirements or standards affecting clinical trials.  Ensures that changes in external requirements and standards are incorporated into clinical policies and procedures.     

• Leads a global working team that administers to clinical policies and procedures, works across functions and operating companies to create/maintain a clinical CAPA process, and leverages the Danaher Business System and tools to implement process improvements that measurably drive compliance and efficiency.

• Collaborates across functions and operating companies to conduct independent quality assurance audits for clinical programs as applicable. 

• Leads the preparation of investigative sites for regulatory inspection, collaborates with both internal and external staff on the implementation of clinical CAPA plans and coordinates the closure of inspectional findings. 

• Responsible for clinical associate training programs related to policies, procedures, and training fundamentals (eg, GCP, design controls, etc). Ensures that key performance indicators are established to measure the effectivity of associate training and development programs, and implements process improvements.

• Performs other duties as assigned.

Job Requirements



Qualifications

This position requires directly-related experience in Clinical Program planning and execution, including an understanding of clinical strategy, and the scientific, statistical, regulatory and compliance requirements of clinical research.  

Demonstrated managerial experienced is required.  

Prior clinical trial inspection experience (both domestic and international) is required. 

Experience with the clinical laboratory, assay/instrument principles involving in vitro diagnostic product design and usage, and pharmaceutical clinical research is desired.

Minimum of 10 years relevant professional experience including:

Managerial responsibilities in Clinical Research with regulatory inspection 5 to 10 years and Quality Assurance/Auditing 5 to 7 years, or Clinical Research Customer Contact 5 to 10 years

B.A. or B.S. in the biological sciences and equivalent job related experience of at least 10 years.

Professional certification as a clinical research associate (CCRA), quality professional (ASQ), regulatory affairs professional (RAC) or clinical research coordinator (CCRC) is preferred.

Advanced degree (MS, PhD) is desirable. 


Other: This position requires a thorough knowledge of the global regulatory requirements related to clinical research, previous experience in clinical research and overseeing regulatory inspection; the demonstrated ability to achieve goals through interaction with individuals not under their direct control; excellent oral and written communication skills, high proficiency with desktop computer office software (MS Office, particularly Word and Excel), ability to travel (20-35% US and/or international), and participation in professional activities outside of normal business hours  




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.