Analyzes the operations of a department or functional unit with the purpose of developing a general systems solution to a business problem that may require automation. Specific duties include assessing the business model, improving/streamlining business processes, and integrating technology, as needed, with the business functions. Specific activities may include participating in client needs assessments as well as evaluating platform feasibility and business and technical software requirements. Position is responsible for reviewing business requirements and conducting impact assessments to understand business and application implications. May advise the client on improvement opportunities that solve business process and technical issues of varying complexities. This is technical and analytical work to develop, design, and/or analyze technical solutions for clients through an appropriate blending of technical knowledge and business problem solving activities.
- Interviews stakeholders in conducting requirement gathering, document requirements in the deployment of business solutions
- Liaison with users in assessment, development, and testing of business solutions.
- Develops and analyzes solutions to business issues, including review and writing of all relevant documentation, including but not limited to functional and technical design requirements.
- Assists in overseeing the development of technical design requirements with developers, programmers, and external suppliers before initiating coding.
- Writes and edits program and system documentation, user manuals, and training materials required to help people use and operate a system.
- Performs computer system validation (CSV) testing on GxP (good practice) clinical systems
- Collaborates and assists in the design of the front-end user interfaces and interactive procedures / tools.
- Performs other duties assigned.
Problem Solving & Impact:
- Establishes a positive relationship by exercising an appropriate action in a timely manner.
- Demonstrates an understanding of the standard technology and systems in place. Contributes to the support of the operation.
- Obtains relevant information from client in order to sufficiently document requirements to a technical expert. Independently resolves routine problems.
Supervision Given/Received:
- Works as a team member by doing own share of work and listening to and acting on expressed needs.
- Typically reports to a Manager or Associate Director.
- Prior work experience in analyzing and implementing GxP systems.
- Prior work experience in developing and executing User Acceptance Testing (UAT) for GxP systems.
- Prior work experience with clinical systems such as electronic Master Files (eTMF) and Clinical Trial Management Systems (CTMS).
- Prior work experience with SharePoint
- Understands basic operation of functional unit and develops awareness of its role in the enterprise.
- Presents and receives ideas clearly both in writing or verbally.
- Works independently on tasks, develops own work schedule and monitors progress against defined parameters.
- Serves as a productive project team member by completing assigned tasks.
- Exhibits working knowledge of specialty work area demonstrated by an understanding of and ability to apply the standards and terminology associated with the work specialty
- Possession of excellent analytical skills.
- Possession of excellent written and oral communication skills.
- Ability to work in a team environment.
- Knowledge and experience with writing requirement documents, and test scripts.
- Customer Service Oriented.
- Reads, writes and speaks English.
- Typically requires 3 – 5 Years of work experience in either a Business Analyst or Quality Assurance (QA) Computer System Validation (CSV) role
- Prior work experience in a non-governmental organization (NGO) or Clinical Research Organization (CRO)
Typical Physical Demands:
- Typical office environment.
- Ability to sit and stand for extended periods of time.
- Ability to lift 5-50 lbs.
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