Quality Manager - Clinical Research in Infectious Diseases (CRID)

Location
Rockville, Maryland
Salary
Competitive
Posted
Sep 13, 2021
Closes
Sep 20, 2021
Ref
2957
Industry
Science
Hours
Full Time
Quality Manager Clinical Research in Infectious Diseases (CRID)

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 Quality Manager to implement and manage quality assurance activities for the CRID project and ensure compliance with all applicable regulatory, GCP, and client standards.

Responsibilities
  • Ensure compliance with project-specific Quality Management Plan (QMP)
  • Conduct protocol audits of CRID studies
  • Support client and regulatory audits and inspections of CRID studies
  • Develop, implement, and report on corrective and preventative action plans (CAPAs), as necessary
  • Implement and maintain a quality metrics database for quality metrics reporting
  • Report on quality assurance activities and quality metrics to the project management and sponsor
  • Promote the use of standard and approved templates for study materials and reports
  • Develop processes and tools for quality control of project deliverables and reports
  • Contribute to CRID project-specific policies, procedures, and plans
  • Advise on project processes and develop plans for continuous quality improvement

Experience
  • Preferred: Bachelor's degree and 6 years related experience or Master's degree a nd 4 years related experience, and demonstrated working knowledge of scientific principles appropriate to the position.
  • Excellent oral and written communication skills.
  • Strong interpersonal skills and ability to deal with staff at all levels with sensitivity and tact.
  • Experience with developing and implementing quality processes in clinical trials
  • 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


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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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