The Emmes Company, LLC is searching for a Clinical Research Quality Manager, Infectious Disease Trialslocated 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
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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.
NOTES:
Telecommuting is allowed.
About The Emmes Company
The Emmes Company, LLC established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six 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.
