The Emmes Company, LLC is searching for a Data Manager/Protocol Monitor 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 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.

Primary Purpose

The Entry-Level Data Manager/Protocol Monitor (DM/PM) is responsible for completing study-specific data management activities in accordance with Good Clinical Practices and other relevant guidelines. The DM/PM works as an integral part of a multidisciplinary project team through the lifecycle of the clinical study, from study design through final analysis. The DM/PM produces study materials to ensure the appropriate data are collected and is responsible for the completeness and accuracy of the study data. The ideal candidate will be detail-oriented, a team player, a clear communicator, and able to multi-task.

Responsibilities

• Work in a team environment to design, develop and manage clinical trial data systems, utilizing strong data management and computing skills
• Design, build, test and validate electronic case report forms (eCRFs)
• Contribute to and comply with standardization efforts
• Develop, generate, manage, and distribute data queries and reports to clinical sites
• Contribute to the quality and accuracy of various reports for the duration of the trial
• Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical study protocol
• Assist in the planning, monitoring, and coordination of the clinical research studies at external sites by facilitating effective communications (oral and written) with internal and external project team members, site study coordinators and investigators to ensure compliance with protocol and overall clinical objectives

Experience

• Bachelor's degree in a scientific discipline preferred
• Strong data management/computer skills; experience with CRF design, EDC systems, or other web-based data collection systems helpful
• Prior experience in clinical research preferred
• Excellent oral and written communication skills
• Skills in prioritization, organization, and time management
• High attention to detail, ability to multi-task and collaborative

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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.