Lab Operations Manager

Company: ICON Strategic Solutions
Location: Carson City
Posted on: May 26, 2023

Job Description:

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Position Summary
The Associate Lab Operations Manager assists with the day-to-day management of studies and vendors assigned to them. This individual has knowledge of external central and third-party testing lab(s) processes and ensures lab vendors contracted to client and Clinical Study Teams, have the proper support to ensure proper vendor setup, governance, and timeline development for key trial deliverables involving these vendors. This position requires both hands on study and vendor management. This role possesses knowledge of GxP, FDA regulations, vendor-sponsor best practices, strong technical skills, and is capable of supporting infrastructure assessment and improvement.
Principal Responsibilities

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  Support the oversight of external, and internal, Biomarker and Bioanalytical labs assigned to them ensuring proper vendor execution and oversight across the portfolio.
  
  
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  Works collaboratively with internal key stakeholders (e.g. Clinical Project Management, Clinical Operations, Biomarker and Bioanalytical Scientific Study Leads, Data Management) to ensure proper alignment and study level execution of scientific and operational strategies of the lab vendors assigned.
  
  
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  Works closely with the Biomarker / Bioanalytical Data Management team to support their management of day-to-day vendor oversight after study setup and/or amendments to study protocols.
  
  
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  Serves as escalation point for vendors assigned from study teams across Seagen's portfolio. Works closely and collaboratively with our Vendor Strategy Management team and Senior Leaders to resolve vendor concerns and milestones.
  
  
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  Attends Clinical Study Team meetings as needed to provide lab vendor support during start-up, amendments, and escalations.
  
  
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  Preparation and review of clinical study documents such as lab specification documents, sample management plans, and laboratory manuals.
  
  
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  Assists with developing presentations and presenting metrics at team meetings.
  
  
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  Identifies, develops, and supports implementation of risk mitigation strategies associated with lab vendors as needed across programs.
  
  
  Qualifications
  
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    Minimum 4 years of relevant work experience including working with Central Labs, Biomarker, and Bioanalytical testing labs
    
    
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    Strong understanding of the industry as it relates to the central and third-party testing lab players and processes
    
    
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    General understanding of GCP and GLP requirements
    
    
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    Prior experience writing, and / or reviewing, lab specification documents and work instructions
    
    
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    Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
    
    
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    Flexible, easily adapts to change, and is energized by challenges and problem-solving
    
    
    Education
    
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    • BS in a Life Science; years of experience may substitute for education
      
      Benefits of Working in ICON:
      Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
      At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
      ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
      If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Keywords: ICON Strategic Solutions, Reno , Lab Operations Manager, Healthcare , Carson City, Nevada