Business Analyst-Clinical Systems Analyst
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. EMMES is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. EMMES is seeking a Business Analyst-Clinical Systems Analyst to support all phases of clinical trials.
The Clinical Systems Analyst is the liaison between the project team (directors, statisticians, protocol monitors, data managers) and the programming team and is the information management specialist for projects. The Clinical Systems Analyst is responsible for managing a projects software development life cycle and ensuring that requirements and specifications for new and existing data systems and data migrations are documented accurately and communicated to the programming group and project team. Additionally, the Clinical Systems Analyst should be familiar with the systems capabilities, limitations, and requirements and ensure that they are clear to project staff. In situations where these appear inharmonious, the Clinical Systems Analyst is expected to work with the programming group and project staff to resolve the apparent conflict.
- Manage a projects software development life cycle for data capture applications (i.e., AdvantageEDC, GlobalTrace, etc.) from requirements gathering to end-user support. This includes developing schedules, defining milestones, and ensuring resource availability.
- Write and maintain thorough requirements for new and existing data systems.
- Maintain comprehensive documentation in accordance with corporate SOPs and ensure Good Technical Practice
- Demonstrate proficiency in development and testing of data system specifications.
- Act as the liaison 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 developments
- Train project staff in development and testing of data system specifications
- Triage and manage end-user support issues for data capture systems and web sites
- Coordinate project informational web site design and development
- Ensure that systems security policies and procedures are maintained by the project
- Prioritize and manage project technical issues and ensure timely completion
- Review project information management needs and propose efficient and economical solutions
- Provide and apply solutions to project and corporate needs
- Demonstrate understanding of project and corporate SOPs by producing work in compliance with the SOPs
- Maintain documentation required by corporate and project SOPs
- Participate in internal audits and other project and corporate quality assurance activities, (e.g., participates in Internal Quality Assurance Team (IQAT) meetings)
- Bachelors degree, preferably in information systems or a health-related/scientific discipline
- 2-3 years clinical trial experience preferred
- Strong computer and analytical skills.
- Experience with system implementation or product development preferred
- 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 implementation and troubleshooting experience preferred
- Knowledge of principles and methods of systems and application implementation, configuration management and maintenance, database management
- Working knowledge of Java and SQL preferred
- 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
EMMES has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.
*For immediate consideration please submit your resume and apply directly through the company website at www.emmes.com.
Please visit our website at www.emmes.com for additional information on our company, studies and history.
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EMMES is proud to be an Equal Opportunity Employer EOE/M/F/D/V