Data Manager (Entry-Level)

Location
Rockville, Maryland
Salary
Competitive
Posted
Apr 05, 2019
Closes
Apr 05, 2019
Ref
2067
Function
Management
Industry
Science
Hours
Full Time
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; Fairfax, 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 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 a Junior Data Manager

Project

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 large 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.

More information about the NIDA CTN can be found here: http://www.nida.nih.gov/CTN/Index.htm

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.

Responsibilities
  • Work in a team environment to design, develop, test and validate electronic case report forms (eCRFs) in a clinical trial data system, utilizing strong data management and computing skills
  • Conduct Advantage eClinical training for clinical sites and work closely with site staff to ensure data is collected consistently and appropriately across the CTN
  • Develop, generate, manage, and distribute data queries and reports to clinical sites
  • Assist in the planning, monitoring, and coordination of clinical research studies at external sites by having effective communications (oral and written) with internal and external project team members, and site study coordinators and investigators to ensure compliance with protocol and overall clinical objectives
  • Create and implement validation processes for multiple methods of data collection
  • Participate in project and corporate quality assurance activities
  • Contribute to the quality and accuracy of various reports for the duration of the trial
  • 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

Experience
  • Bachelor's degree in a scientific discipline
  • Must have prior Internship research experience or 1 year in a full-time research position, preferably in clinical research
  • Strong data management/computer skills; experience with CRF design, EDC systems, or other web-based data collection systems a plus
  • Prior experience in substance use disorder or mental health research is a plus
  • Strong attention to detail required
  • Excellent oral and written communication skills
  • Personable and able to work well as part of a team
  • Skills in prioritization, organization, and time management

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs

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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.

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