Sr Business Analyst/Product Owner with Clinical Research

6 Months C2H

Rockville, MD-Hybrid

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
• 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