Job Role: Business Analyst/Product Owner
Location: Rockville, MD (Hybrid) able work on Fridays.
Duration: 6 months
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
Thanks & Best Regards,
Vignan
Director – Business Development
Email: [email protected]