Drug Research Business Systesm Analyst
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Hawkins Point Partners has an immediate need on its Cambridge, Massachusetts team for a Business Systems Analyst with expertise supporting drug research applications. Familiarity with GxP, CFR 21 Part 11 and systems validation along with life sciences, industry experience is required. This person will serve as a trusted advisor between scientific (clinical research) and technical teams. Strong documentation and requirements management skills required. The ideal candidate will be expected to partner with the senior business analysts and the Data Management organization to support a suite of clinical research and R&D systems.
Seven years of experience as a Business Analyst and proven skills authoring SDLC deliverables in a GxP, CFR 21 Part 11 environment.
Ability to develop process knowledge to translate to business and technical requirements.
Strong Business Systems Analyst skills, ability to document business processes and use cases.
software support throughout the life of assigned projects in clinical and drug research.
Assist in testing preparation and implementation of new applications supporting R&D and clinical data capture.
Support development of training materials and facilitation of end user training sessions.
Contribute to the creation of operational support documentation along with other ad hoc tasks requested. Must have experience supporting GxP and 21 CFR validated systems.
Knowledge of Electronic Data Capture system is preferred but not mandatory.
Bachelor of Science degree or related discipline is required.