The Emmes Company, LLC is searching for a Data Manager/Protocol Monitor located in our Rockville, Maryland or Frederick, Maryland office. Emmes provides flexibility for office location preference, dependent upon position.
This position will support one or more studies within the Vaccine and Infectious Disease (VID) research team that provides data management and statistical support for more than 200 clinical research studies, domestically and internationally. The VID group supports infectious disease research across a wide range of disease areas, including:Malaria, Tuberculosis, Influenza, Ebola, MRSA, STI and Enteric pathogens, and emerging infectious diseases. VID supports Phase 1-4 clinical trials investigating vaccines and treatments for bacterial, viral, and parasitic agents, as well as epidemiological studies. Primary services include statistical design and analysis; bioinformatics support; implementation of Emmes’ proprietary software for electronic data collection, data management, and electronic specimen tracking; preparation of study-related materials and web site development; generation of safety, regulatory, and final reports and manuscripts; clinical site training, assessment, and technical assistance; and study communication and collaboration.
The 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. Data management deliverables include data collection forms, electronic case report forms, data integrity checks, manuals of procedure, and data collection guidelines. The DM/PM also performs quality control of data utilized in safety and analysis reports. An experienced DM/PM will be expected to apply previous experience with database design (either clinical or non-clinical) to quickly learn Emmes’ proprietary systems for eCRF development and query generation. An experienced DM/PM is also expected to work independently to extract required data collection elements from the protocol to develop data collection forms, develop supplemental study documents, and coordinate study report generation. The ideal candidate will be detail-oriented, a team player, a clear communicator, and able to multi-task.
Work in a team environment to design, develop, and manage clinical trial data systems, utilizing critical thinking and strong data management and computing skills
Develop data collection forms, manual of procedures, and other supplemental study documents based on the study protocol and project standards
Design, build, test, and validate electronic case report forms (eCRFs)
Develop, generate, manage, and distribute data queries and reports to clinical sites
Coordinate report generation and contribute to the quality and accuracy of reports for the duration of the trial
Assist in the planning, monitoring, and coordination of 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, and the study sponsor to ensure compliance with protocol and overall clinical objectives
Ensure adherence to project and corporate standard operating procedures (SOPs), as well as federal and ICH guidelines in maintaining data integrity and quality throughout a clinical study
Contribute to and comply with project standardization efforts
Duties may include medical writing, as well as planning and implementing QC steps, such as checking tables, figures, and listings; verifying data entry; reviewing data files; and reconciling text and tables
Bachelor’s or Master’s degree required (scientific discipline preferred)
2+ years of experience in data management and/or database design (experience in a clinical research setting is a plus)
Experience translating data needs into effectively written requirements for database design
Experience identifying and applying data querying criteria to clean complex datasets
Experience in infectious disease research is a plus
Strong attention to detail is required
Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues
Ability to quickly learn and apply new software packages
Skills in prioritization, problem solving, organization, decision-making, time management, and planning
Ability to work effectively both independently and in a team-based environment
Ideal candidate will be receptive to direction and feedback from others on their team
Ideal candidate will be self-motivated, demonstrating initiative and critical thinking skills in managing daily tasks and identifying process improvements
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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.
Internal Number: 2064
About The Emmes Company, LLC
The Emmes Company, LLC (“Emmes”), 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, 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.