The Emmes Company, LLC is searching for a Clinical Systems Analyst - Business Analyst
based out of our Rockville, Maryland or Frederick, Maryland office. Emmes provides flexibility for the office location or work remote preference dependent upon position.
The Emmes Company, LLC 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, 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 Clinical Systems Analyst (CSA)
is the liaison between the project team and the programming team. The CSA is responsible for managing a project's software development life cycle, assisting with implementation, configuration, training and support of Emmes' suite of software products for project needs, ensuring that requirements and specifications for systems are documented accurately and communicated to the programming group and project team, and assuring validation and 21 CFR Part 11 adherence. The CSA provides consultation on software products, IT needs and process improvements. Responsibilities
- Manage a project's software development life cycle for Emmes' suite of software products; this includes developing timelines and coordinating and leading release meetings
- Communicate and liaise between the IT staff and project staff to ensure mutual understanding with regards to protocol workflow, technical requirements, time lines, system functionality, system capabilities, and new product features
- Provide domain expertise with Emmes' suite of software products
- Elicit requirements and write functional and configuration requirements for systems
- Evaluate requirements and determine feasibility based on system capabilities
- Research and propose efficient and economical solutions
- Create test plans and test scripts for functional requirements
- Troubleshoot system issues
- Prioritize and manage project technical issues and ensure timely completion
- Maintain comprehensive documentation in accordance with corporate SOPs and ensure Good Documentation Practice
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- Bachelor's degree (in information systems preferred) and 2 years related experience or Master's degree with demonstrated working knowledge of scientific principles appropriate to the position
- Strong computer and analytical skills
- Previous experience with requirements documentation and systems testing preferred
- Attention to detail is a necessity
- Technical understanding of operating system and database concepts, and application troubleshooting experience preferred
- Knowledge of principles and methods of systems and application implementation, configuration management and maintenance, database management
- Excellent written and oral communication skills and the ability to interact with people of all technical levels
- Excellent interpersonal skills, especially the ability to advocate, negotiate, listen and collaborate with a variety of individuals and groups
- Ability to work both independently and in a complex team environment
- Ability to manage multiple tasks
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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.