Contractor | IT Outsourcing & Consulting1 Week Ago
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ERPMark is Hiring a Business Analyst/Product Owner Near Rockville, MD
Needed experience in NIH or Clinical Research.Responsibilities
Collaborate with stakeholders to gather and document detailed requirements and develop workflow for new features and product enhancements
Manage stakeholder engagement through working group meetings and provides ongoing communication and regular updates to key stakeholders
Conduct thorough analysis of user needs, industry trends, and regulatory requirements to inform product development
Maintain and prioritize the product backlog, ensuring that it aligns with the overall product vision and strategy to ensure the system meets the needs of the customer
Manage all stages of the product creation and actively participate with the development team in the backlog grooming process, refining, and prioritizing user stories using agile scrum methodologies,
Create and/or review project artifacts, and deliverables
Collaborate with Product Owners
Support operations and maintenance
Support computer system validation and adhere to computer system validation (CSV) SOPs
Remain current and participate in continuing education and training opportunities related to clinical informatics
Requirements
Bachelor’s degree in Computer Science, or Information Systems, or Life Sciences or Biology or a suitable combination of education, training, and experience
5 years of experience serving as Business Analyst for custom-developed software solutions
3 years of demonstrated experience in leading the successful delivery of complex IT systems using technologies such as .NET and SQL Server
3 years of experience in clinical research informatics with knowledge of clinical research processes and informatics needs
Experience in leading a multidisciplinary team
Strong facilitation, planning, and organizational skills
Demonstrated experience in Agile Scrum and use of application lifecycle management tools like Azure DevOps
Excellent verbal and written communication skills to facilitate knowledge acquisition business modeling with both operational and managerial staff
Strong technical writing and presentation skills
Ability to work in a life-sciences regulated environment
Preferred Skills And Experiences
Experience leading the implementation of life-sciences projects at NIH
Knowledge of software quality assurance, validation, and industry standards (e.g., CMMI)
Familiarity with 21 CFR Part 11 and Good Clinical Practice