The Emmes Company, LLC is searching for a Senior Data Manager located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for office location preference, dependent upon position.
This position will support The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) research team that provides data management and statistical support for clinical studies. The NIDA CTN is a national network of research sites conducting studies of behavioral, pharmacological, and integrated treatment interventions in rigorous, multi-site clinical trials. The objective is to “bridge the gap” between science and practice. The NIDA CTN is comprised of 13 Nodes, associated with approximately 240 Sites. Primary services that the DSC provides for the NIDA CTN include developing and maintaining an electronic data capture system, designing and performing statistical analyses, monitoring the quality of study data and the progress of the study, preparing study reports, assisting in protocol development, and assisting in the reporting of study findings.
Congress has recently allocated funding towards the HEAL (Helping to End Addiction Long-term) Initiative , an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. A portion of the funds have been allocated to NIDA and the CTN in particular. With this increase, our project will have the opportunity to play an important role in advancing this research to combat the opioid crisis and develop more customized, high-quality treatments for addiction and pain, as well as harness implementation science to bring evidence-based changes to our healthcare system.
The Data Manager 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 lifecycle of the clinical study from study design through final analysis and study closeout. The Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and works closely with site staff to achieve this. 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.
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)
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
Assist in the creation of the data system training process, including the development of training materials
Serve as a representative of the DSC to external investigators
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
Bachelor’s degree (scientific discipline preferred) and 5 years of related experience or master’s degree with 3 years of related experience and demonstrated working knowledge of scientific principles appropriate to the position
Strong data management/computer skills; experience with CRF design, EDC systems, or other web-based data collection systems helpful
Experience in clinical research, specifically oncology, hematopoietic stem cell transplantation and cellular therapy is a plus
Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal & external clients and colleagues
Skills in prioritization, problem-solving, organization, and time management
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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: 2181/2182
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.