Data Manager/Protocol Monitor

Location
Rockville, Maryland
Posted
Dec 11, 2018
Closes
Dec 19, 2018
Function
Management
Industry
Science
Hours
Full Time

The Emmes Corporation, established in 1977, is a privately-held, woman-owned 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. Emmes is seeking an entry-level Data Manager/Protocol Monitors to support The National Myelodysplastic Syndromes (MDS) study team.

Project

This position will support The National MDS Study for which Emmes provides support as the Data Coordinating Center (DCC). The National MDS Study is a prospective cohort study collecting biospecimens and clinical data on participants diagnosed with a group of rare blood disorders called MDS and other related conditions to build a resource to help future scientists learn more about the diagnosis and treatment of MDS. Primary services include statistical design and analysis; bioinformatics support; implementation of Emmes’ proprietary software for electronic data collection, data management, and electronic specimen tracking in conjunction with data collection systems from other external partners; preparation of study-related materials and web site development; generation of study 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 database delivery to the client. The Data Manager/Protocol Monitor produces study materials to ensure the appropriate data are collected, and is responsible for collaborating with partners to ensure the completeness and accuracy of the study data.

Responsibilities

  • Work in a team environment to design, develop and manage clinical trial data systems, utilizing strong data management, computing, and communication skills
  • Provide training and support to clinical sites, external collaborators, and sponsors to optimize clinical study operations
  • Liaise with study laboratory and other study collaborators to continuously monitor and improve study processes, systems and workflows
  • Troubleshoot any issues or questions that may arise from clinical site staff and other study contributors
  • Develop, generate, manage, and distribute data queries and reports to clinical sites
  • Design, build, test and validate electronic case report forms (eCRFs)
  • 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 the clinical study protocol
  • Contribute to development of study promotional and educational materials to enhance accrual and engagement in the study.
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 work collaboratively

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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