Data Manager

Location
Rockville, Maryland
Salary
Competitive
Posted
Apr 05, 2019
Closes
Apr 05, 2019
Ref
2003
Function
Management
Industry
Science
Hours
Full Time
The Emmes Corporation, established in 1977, is a women-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.

Primary Purpose

This position will support The National Eye Institute Support (NEIS) project . Emmes staff collaborates closely with NEI investigators in support of various activities, including statistical and scientific expertise in study design, protocol development and data analysis, study implementation, site monitoring, protocol navigation and coordination, regulatory submissions, and computer system development for data collection and quality control. Additional multi-center trials have been implemented, which expanded Emmes' support to clinics outside NEIS.

Trials conducted under this contract span various diseases, including inflammatory disorders, motility disorders, age-related dysfunction, and genetic disorders. The clinical research coordinated by NEIS undertakes a variety of study designs, such as single-center, multi-center, randomized and non-randomized clinical trials, genetic, and natural history studies. Currently activated protocols include trials that examine novel approaches in treating participants with age-related macular degeneration, diabetic macular edema, branch and central retinal vein occlusion, retinitis pigmentosa, von hippel landau disease, x-linked retinoschisis, scleritis, and uveitis.

Responsibilities
  • 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
  • Creates and implements validation processes for multiple methods of data collection
  • Performs internal audits and participates in other 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 (scientific discipline preferred) and 2 years of related experience or Master's degree with demonstrated working knowledge of scientific principles appropriate to the position.
  • Strong data management/computer skills; prior experience with CRF design, EDC systems, or other web based data collection systems helpful
  • Excellent oral and written communication skills
  • Skills in prioritization, organization, and time management
  • High attention to detail, ability to multi-task and collaborative

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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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