EDC Quality Manager

Location
Rockville, Maryland
Salary
Competitive
Posted
Oct 10, 2019
Closes
Nov 09, 2019
Ref
2228
Function
Management
Industry
Science
Hours
Full Time
The Emmes Company, LLC is searching for an EDC Quality Manager located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia office. Emmes provides flexibility for office location preference, dependent upon position.

The Emmes Company, LLC is a 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

The EDC Quality Manager is responsible for ensuring that the EDC development team successfully performs the expected verification and validation tasks for electronic data capture systems and that all system releases are high quality. This position collaborates with the product owner to ensure all release documentation is accurate and complete, and EDC releases are delivered on time.

Responsibilities
  • Defines EDC QA standards and processes; plans/organizes necessary test passes; helps triage bugs and drive issues to resolutions; keeps the data system development team and VID QA manager informed of QA status
  • Tracks and reports test results, troubleshoots, and coordinates fixes with the EDC development team
  • Ensures all release documentation is completed correctly and on time; work closely with key stakeholders to resolve related issues
  • Assesses the status of software releases to ensure timely delivery with high quality
  • Works with different teams (Development/Product Management/Operation/Support) to collect necessary information to assure the QA coverage and provide feedback on quality issues
  • Works with EDC Quality Analyst and software development teams to set their priorities and remove roadblocks to ensure sufficient coverage for the release
  • Reviews testing processes to ensure quality testing
  • Devises and track metrics for measuring and reporting QA effectiveness.
  • Makes recommendations for process improvements and standardization
  • Trains employees in development of enhancement requirements, test plans and test scripts
  • Conducts performance conversations and reviews
  • Other duties as assigned

Experience
  • Bachelor's degree in a computer science, engineering, or related field, or equivalent experience
  • Minimum 5 years of experience in software quality assurance
  • Demonstrated experience implementing software QA methodologies, tools, and processes, SQL and scripting
  • Practical experience with systems regulated by 21 CFR Part 11, ICH E6 (R2), GCP, and other applicable regulations
  • Self-motivated, proactive and detail-oriented work style required
  • Management experience preferred
  • Experience with EDC, EHR, and/or other Health IT systems is preferred
  • Working knowledge of relational databases such as MS SQL Server, MySQL, or Oracle is preferred
  • Working knowledge of browser debugging tools and automated testing is preferred
  • Experience working in a Scrum team is preferred


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The Emmes Company, LLC 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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