Data Manager/Protocol Monitor
Posted on Nov 19, 2018 by EMMES Corporation
The EMMES Corporation, established in 1977, is a privately-owned 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 offer statistical support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Emmes is seeking two experienced Data Manager/Protocol Monitors to support its group of Vaccine and Infectious Disease studies
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 is responsible for completing study-specific data management activities in accordance with Good Clinical Practices and other relevant guidelines. The Data Manager/Protocol Monitor works as an integral part of a multidisciplinary project team through the lifecycle of the clinical study, from study design through final analysis. The Data Manager/Protocol Monitor 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 Data Manager/Protocol Monitor also performs quality control of data displays in analysis reports. An experienced Data Manager/Protocol Monitor will quickly learn Emmes' proprietary systems for eCRF development and query generation, and is also expected to work independently to develop data collection forms based on the protocol, draft study documents, and coordinate study report generation.
- Work in a team environment to design, develop and manage clinical trial data systems, utilizing strong data management and computing skills
- Develop data collection forms and manual of procedures 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 SAS output, and reconciling text and tables
- Bachelor's degree in a scientific discipline preferred
- 2 years of experience, preferably in clinical research
- Strong data management/computer skills; experience with CRF design, EDC systems, or other web based data collection systems helpful Prior experience in infectious disease research is a plus Strong attention to detail required Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues Skills in prioritization, problem solving, organization, decision making, time management and planning
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs
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The EMMES Corporation 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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