Details
Posted: 07-Aug-24
Location: New Haven, Connecticut
Type: Full-time
Salary: Open
1. Develops the initial project charter and clarify the project scope, requirements, measurable outcomes, and project benefits in collaboration with process owners. 2. Documents the "as is" and "to be" business processes using standard process modeling tools and process improvement methodologies. 3. Decomposes high-level business and user requirements into functional requirements. Manages the development of functional specifications by collaborating with process owners; gathering business requirements; creating functional specifications; and identifying, documenting, and resolving design issues 4. Represents requirements using alternative views, such as analysis models (diagrams), prototypes, or scenarios. Provides compelling and concise analysis to enable business owners to make well informed decisions regarding options for problem resolution and opportunity realization. 5. Leads requirements analysis and verification, ensuring that requirement statements are complete, consistent, concise, comprehensible, traceable, feasible, unambiguous, and verifiable, and that they conform to standards. 6. Contributes in testing and quality assurance process. Collaborates with developers and end-users to insure that application functionality meets client needs. Tests solutions, problem-solve issues, and coordinate enhancements. 7. Responsible for requirements prioritization and solution risk analysis. 8. Plans and communicates the departmental readiness plan. Supports metrics integration and execution for optimal results. 9. Develops and delivers training to end users. 10. May perform other duties as assigned.
Required Skill/ability 1: Experience developing REDCap projects and solutions. Strong analytical and problem-solving skills. Ability to review customer requirements and translate into data capture and storage strategies. Capable of developing creative solutions to complex problems.
Required Skill/ability 2: Strong communication and collaboration skills. Demonstrates a high degree of customer service. Must communicate effectively and diplomatically in written and verbal forms with internal and external contacts, faculty, researchers and staff at all levels.
Required Skill/ability 3: Proficient at working in team environments as well as self-directed independent projects. Ability to manage multiple projects concurrently while balancing priorities and deadlines. Demonstrates leadership skills needed to successfully complete projects.
Required Skill/ability 4: Understanding of regulatory compliance. Ability to understand and communicate implications of federal regulations and university policies related to clinical research and data compliance.
Preferred Education: Bachelor's degree or a combination of 5 years work in a related IT or research role. Knowledge of clinical trial design, HIPAA regulations and IRB requirements. Prior experience as a REDCap administrator and developing REDCap projects. Knowledge of 21CFR Part 11 regulations, GCP requirements, and data management practices for FDA clinical trials.
Bachelor's degree or a combination of 5 years work in a related IT or research role. Knowledge of clinical trial design, HIPAA regulations and IRB requirements. Prior experience as a REDCap administrator and developing REDCap projects. Knowledge of 21CFR Part 11 regulations, GCP requirements, and data management practices for FDA clinical trials.
Bachelor's degree in business, technology or related field. Four years of related experience in analysis of business needs and development of related business systems or an equivalent combination of education and experience.