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Clinical Research Quality Manager, Infectious Disease Trials

Company: The Emmes Company, LLC
Location: Rockville
Posted on: February 24, 2021

Job Description:

The Emmes Company, LLC is searching for a Clinical Research Quality Manager, Infectious Disease Trials located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for office location preference, dependent upon position. The Emmes Company, LLC is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over seven hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose The Emmes CRID project is seeking a Clinical Research Quality Manager, Infectious Disease Trials to implement and manage quality assurance activities for the project, within the larger framework of adherence to NIH-DMID and Emmes corporate policies and procedures, and compliance with all applicable regulatory and GXP standards. Responsibilities

  • Conducts protocol audits of CRID studies
  • Develops, implements and reports on corrective and preventative action plans (CAPAs), as necessary
  • Implements and maintains a quality metrics database for quality metrics reporting
  • Reports on quality assurance activities and quality metrics to the project management and sponsor
  • Promotes the use of standard and approved templates for study materials and reports on the CRID project
  • Develops processes and tools for quality control of project deliverables and reports
  • Contribute to CRID project-specific policies and standard operating procedures for project-specific tasks
  • Advises on project processes and develop plans for continuous quality improvement
  • Other duties as assigned Experience
    • Bachelor's degree in Life Sciences or a related scientific field
    • 7 years' experience working in both clinical research management and quality management
    • Data management skills to develop and use a quality metrics database
    • Excellent oral and written communication skills
    • Strong interpersonal skills and ability to deal with staff at all levels with sensitivity and tact
    • Demonstrated ability to foster concepts of teamwork, research integrity, ethical conduct and personal responsibility
    • Ability to self-direct and work independently and in a complex team environment
    • Knowledge of clinical research including the critical elements for the development and execution of clinical trials or research studies
    • Strong skills in prioritization, organization, problem solving, decision-making, time management, mentoring and planning CONNECT WITH US!! Follow us on Twitter - @EmmesCRO Find us on LinkedIn - The Emmes Company, LLC The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Keywords: The Emmes Company, LLC, Rockville , Clinical Research Quality Manager, Infectious Disease Trials, Executive , Rockville, Maryland

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