Data Manager (Mid-Level)

Expiring today

Location
Rockville, Maryland
Salary
Competitive
Posted
Jul 14, 2019
Closes
Jul 17, 2019
Ref
2088
Function
Management
Industry
Science
Hours
Full Time
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.

Primary Purpose

This position is for The National Eye Institute Support (NEIS) project . Emmes staff collaborates closely with the 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, as well as, computer system development for data collection and quality control. Additional multi-center trials have been implemented, which expanded Emmes' support to clinics outside the NEI.

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, as well as, 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 contribute and oversee the design and development of clinical trial electronic data capture systems, utilizing strong data management and computing skills
  • Design, build, test and validate electronic case report forms (eCRFs)
  • Collaborate with Project Manager to ensure deliverables are of the highest quality
  • Develop, generate, and manage data queries and reports for the clinical sites
  • Contribute to the quality and accuracy of various reports for the duration of the trial
  • Create and implement validation processes for multiple methods of data collection
  • Perform data system trainings for clinical sites and communicate with site staff to resolve technical issues
  • Critically review study materials, such as protocols, MOPs and study specific guidelines
  • Perform internal audits as well as participate in project and corporate 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

Experience
  • Bachelor's degree (scientific discipline preferred) and 3 years of related experience or Master's degree with demonstrated working knowledge of scientific principles appropriate to the position, and at least 1 year of related experience
  • Strong technical data management/computer skills; prior experience with CRF design and EDC systems or other web-based data collection systems
  • Prior experience in clinical research
  • Excellent oral and written communication skills
  • Skills in prioritization, organization, and time management
  • High attention to detail, ability to multi-task and collaborate with a team

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The Emmes Company 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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