Senior Manager, Clinical Data Informatics

POSITION SUMMARY:

The Senior Manager, Clinical Data Informatics, plays a critical role in advancing the ASH Research Collaborative (ASH RC) Data Hub program as a primary business analyst for the design, development, and implementation of technology tools used by ASH RC participants and stakeholders. This position bridges the gap between clinical subject matter experts and technology teams to ensure that products meet the needs of researchers, clinicians, industry, and federal agency partners.

The ideal candidate possesses in-depth clinical informatics expertise and direct healthcare experience, enabling them to translate complex clinical workflows and research objectives into technical requirements. They leverage their knowledge of electronic health record (EHR) data and real-world data to guide the development of tools and outputs that support clinical researchers, health care monitoring, and regulatory research use cases. A key responsibility includes proactively identifying and addressing data quality issues arising from data submissions or analysis and leading the design and execution of solutions to ensure high-quality, research data sets.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Requirements Design and Product Development

• Serve as a business analyst to elicit technical and non-technical stakeholder requirements through interviews, workshops, workflow analysis, and data review.
• Translate high-level business objectives into detailed business requirements, user stories, and functional specifications to drive product development.
• Develop wireframes, process flows, algorithms, metric and statistic calculation specifications, pseudocode, data visualization specifications, and database design requirements.
• Collaborate with internal and contracted technology teams to oversee design, development, and implementation of technology tools that meet the needs of ASH RC’s clinical, research, and regulatory stakeholders.
• Maintain and groom product backlog and contribute to Agile sprint planning.
• Coordinate requirement walk-throughs and sign-offs with stakeholders to ensure use cases and process models accurately portray specific business needs.
• Clearly and routinely communicate with stakeholders about project timelines, status, and potential roadblocks.

Data Quality & Informatics

• Apply advanced clinical informatics knowledge to ensure EHR and other real-world data are accurately represented in products and outputs.
• Identify and investigate data quality issues related to site submissions, data integration, or analytical methods.
• Develop and lead implementation of data quality improvement solutions, including validation protocols, enhanced algorithms, and automated checks.
• Conduct data analysis using relational databases and SQL to validate algorithms, clinical concept mappings, and statistical calculations.

Quality Assurance and Testing

• Create user acceptance test plans to validate business requirements, contractual obligations, and regulatory requirements.
• Develop functional test plans in collaboration with technology implementation teams to ensure that detailed technical specifications are accurately implemented.
• Lead UAT sessions and facilitate issue resolution with stakeholders.

Project Management

• Act as the bridge between clinical subject matter experts and technology teams to ensure tools meet stakeholder needs.
• Elicit and document requirements, translating clinical workflows into user stories, wireframes, and technical specifications.
• Maintain and prioritize the product backlog; coordinate Agile sprint planning and execution.
• Use Jira to manage backlog, track sprints, and monitor project progress.
• Facilitate requirement walk-throughs and sign-offs with stakeholders to confirm accuracy and alignment.
• Provide regular communication on project timelines, status updates, and potential risks or roadblocks.
• Create and manage user acceptance test (UAT) plans; lead sessions and coordinate resolution of issues.
• Ensure deliverables meet business, functional, and regulatory requirements.
• Apply structured project management practices to drive efficiency, transparency, and high-quality outcomes.

QUALIFICATIONS, KNOWLEDGE & SKILLS

• Bachelor’s degree, preferably in health sciences, informatics, information technology, data analysis, or a related field. Master’s preferred and 7 years of experience.
• Business analyst experience in healthcare or clinical research environments, functioning as a bridge between technology teams and clinical subject matter experts.
• Demonstrated experience with clinical workflows and the application of technology within a clinical setting.
• Expertise in clinical informatics, including EHR data and clinical codes, including but not limited to ICD-9, ICD-10, SNOMED, LOINC, RXNORM, and CPT codes.
• Proficiency in SQL and relational databases for data analysis, algorithm validation, and troubleshooting.
• Experience working within an Agile development framework, including scientific analysis requirements, conceptual data modeling and process modeling, data integration and quality assurance, data visualization, and data entry tools.
• Strong structured problem-solving skills, with a commitment to continuous improvement and a keen attention to detail.
• Exceptional verbal and written communication skills, with the ability to manage requirements meetings, workshops, and end user demos.
• Experience creating reports and visualizations using business intelligence tools.
• Experience with hematology clinical terms and research methodologies.
• Experience with regulatory and research standards for real world data (e.g., FDA real world evidence guidance).

PHYSICAL REQUIREMENTS

• Requires ability to speak audibly and listen actively.
• Ability to use computers telephones and other office equipment
• Will require minimal air travel.