Data Manager/Protocol Monitor
The EMMES Corporation, established in 1977, is a privately-owned 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 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 an experienced Data Manager/Protocol Monitor
This position will support a pediatric study that is responsible for developing and supporting a comprehensive national research and training effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, infancy, and childhood using pharmaceuticals that are appropriately tested within their target populations. These activities are intended to improve pediatric drug therapeutics through preclinical and clinical testing that lead to drug labeling change.
- 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 types of clinical study reports for the duration of the trial
- Maintains frequent email and/or telephone contact with clinical site coordinators to ensure the study is being conducted per protocol and study policies. Tracks site communications
- Contributes to weekly site management meetings and monthly team meetings
- Assists in internal audits and other project and quality assurance activities
- 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 in a scientific discipline preferred
- 2 years of experience in clinical research site management Strong data management/computer skills; experience with CRF design, EDC systems, or other web based data collection systems helpful Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients and colleagues Skills in prioritization, problem solving, organization, decision making, time management and planning
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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.