Data Manager (Pediatrics)

Location
Rockville, Maryland
Salary
Competitive
Posted
Jun 13, 2019
Closes
Jun 21, 2019
Ref
2130
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 fifty staff worldwide with offices located in Frederick, Maryland; McLean, 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.

The clinical studies we support impact public health initiatives on a global scale occurring in more than sixty countries spanning six continents. We are dedicated to providing exceptional 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 a Data Manager.

Project

This position will support a large pediatric research network that is responsible for developing and implementing multiple studies to increase the knowledge base for treating diseases during pregnancy, infancy, and childhood. These activities are intended to improve pediatric drug therapeutics through pre-clinical and clinical research that lead to drug labeling changes. Areas of research include anti-infectives, asthma treatment, anti-psychotics, and treatment for congenital heart disease in pediatric populations. The project supports Phase I through IV studies of various design including, observational studies, double-masked, randomized, placebo-controlled trials, and pharmacokinetic research. Under this contract, Emmes' services include statistical design and analysis, data management, full regulatory obligations, safety oversight and monitoring, and clinical site monitoring.

The Data Manager (DM) works as an integral part of a multidisciplinary project team throughout the lifecycle of the clinical study, from study design through final analysis. The DM produces study materials to ensure the appropriate data are collected and is responsible for the completeness and accuracy of the study data in accordance with Good Clinical Practices and other relevant guidelines. Following training, data managers contribute to deliverables including data collection forms, design and implementation of Emmes' proprietary electronic data capture (EDC) system , data query checks, and data collection guidelines. The DM also serves as the primary point of contact for clinical sites regarding protocol and/or data collection questions and triages communications as appropriate.

Data Manager Responsibilities
  • Work in a team environment to design, develop and manage clinical trial data systems, utilizing strong data management 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 types of clinical study reports for the duration of the trial
  • Develop site training materials and conduct training sessions on use of the EDC system
  • 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 preferred
  • Prior data management/computer skills; experience with CRF design, EDC systems, or other web-based data collection systems helpful
  • Experience in clinical research preferred
  • Excellent oral and written communication skills
  • 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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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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