The Emmes Company, LLC established in 1977, 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. <br /><br />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. <br /><br /><strong> Primary Purpose </strong> <br /><br />This position will provide data management support for the Data Coordinating Center (DCC) of the National NeuroAIDS Tissue Consortium (NNTC). The NNTC is focused on facilitating translational research on the pathogenesis of HIV and HIV related disorders. The NNTC DCC group at Emmes supports four site-based specimen banks, each of which is responsible for collecting, storing, and distributing central nervous system, peripheral organ, and body fluid specimens to qualified researchers from around the world. The NNTC DCC provides multi-faceted support including data management, protocol monitoring, site monitoring, specimen request application review and processing, and metrics reporting on the overall performance of the consortium. <br /><br />The <strong> Data Manager </strong> is responsible for completing study and site-specific data management activities in accordance with Good Clinical Practices and other relevant guidelines. The Data Manager works as an integral part of a multidisciplinary team through the initial receipt of specimen request applications through final approval of these applications by the NNTC Allocations Committee. The Data Manager serves as the intermediary between specimen requestors and the four individual specimen banks. The Data Manager is responsible for the completeness and accuracy of the study data in the electronic database. Data management deliverables include electronic case report forms, data integrity checks, data collection guidelines, and user's guides. The Data Manager also performs quality control of study-specific reports. <br /><br /><strong> Responsibilities </strong> <br /> <ul> <li> Coordinate the receipt and processing of specimen and/or data request applications using online content management systems </li> <li> Work in a team environment to design, develop and manage clinical data systems, utilizing strong data management and computing skills </li> <li> Design, build, test and validate electronic case report forms (eCRFs) </li> <li> Develop, generate, manage, and distribute data queries and reports to clinical sites </li> <li> Create and implement validation processes for multiple methods of data collection </li> <li> Perform internal and external data audits and participate in other project and corporate quality assurance activities </li> <li> Contribute to the quality and accuracy of various reports for the duration of the study </li> <li> 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 </li> </ul> <br /> <strong> Experience </strong> <br /> <ul> <li> Bachelor's degree in a scientific discipline required </li> <li> Strong data management/computer skills; prior experience with statistical packages including SPSS or SAS, CRF design, EDC systems, or other web-based data collection systems helpful </li> <li> Prior experience in clinical research preferred </li> <li> Excellent oral and written communication skills </li> <li> Skills in prioritization, organization, and time management </li> <li> High attention to detail, ability to multi-task and collaborative </li> </ul> <br /><br /><strong> CONNECT WITH US!! </strong> <br /><br />Follow us on Twitter – EmmesCRO <br /><br />Find us on LinkedIn – The Emmes Company <br /><br />Emmes 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.