Clinical Research Quality Manager, Infectious Disease Trials

Location
Rockville, Maryland
Salary
Competitive
Posted
Apr 10, 2021
Closes
May 10, 2021
Ref
2772
Industry
Science
Hours
Full Time
Clinical Research Quality Manager, Infectious Disease Trials

US Remote Worker

The Emmes Company, LLC ("Emmes) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

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


Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


CONNECT WITH US!

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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.

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