business analyst in clinical data management

Astek; United States; On-site; USD 29,000 - 43,000; Full time

Benefits offered by this job

Multisport

Private medical care

Life insurance

Team events

Career development

Mentoring

Referral bonus up to 7000 PLN

Job summary

Astek предоставляет IT-услуги и консалтинг. Роль поддерживает клиента в области наук о жизни и управляет продуктом, фокусируясь на клинических данных и AI-инструментах.

Задачи включают формирование видения продукта, работу со стратегией, планирование релизов и обеспечение соответствия регуляторным требованиям. Требуется обширный опыт в бизнес-аналитике и управлении продуктами в Life Sciences.

Qualifications

• 10+ лет опыта в бизнес-анализе, продуктовом анализе или управлении продуктами.
• Не менее 5 лет опыта в Life Sciences, особенно клиническая разработка/управление данными/операции клинических испытаний.
• Опыт создания и развития сложных масштабируемых цифровых продуктов.
• Глубокие знания клинических процессов и данных.
• Хорошие знания архитектуры и технологий, особенно REST API, микросервисы, интеграции данных в облаке.
• Знание регуляторных требований и валидационных процессов, GxP, CSV/CSA, 21 CFR Part 11.
• Опыт лидерства и наставничества бизнес-аналитиков.
• Умение работать с топ-менеджерами и влиять на решения без формального полномочия.
• Сильные коммуникативные навыки и свободное владение английским языком.
• Отличное знание Jira, Confluence и Agile/SAFe.
• Практический опыт использования GenAI/LLM инструментов для улучшения аналитической работы.

Responsibilities

• Collaborate with the Product Manager to define the product vision, strategy, and roadmap, co-create the MVP scope, and plan subsequent releases.
• Prioritize and develop the Product Backlog, considering business needs, technical debt, and compliance requirements.
• Conduct business analysis throughout the product lifecycle.
• Translate Clinical Data Management needs into product requirements, user stories, acceptance criteria, target processes, and workflows.
• Define requirements for key platform features, including AI-driven discrepancy detection, HITL, automated query generation, Medidata Rave integrations, rule libraries, monitoring, governance, and GxP auditability.
• Connect business, technology, architecture, AI/ML, UX, and regulatory perspectives.
• Build and develop best practices for business analysis, requirements engineering, and documentation.
• Collaborate with Clinical Data Management SMEs, Data Science/AI, Engineering, Enterprise Architecture, Quality & Validation, and UX teams.
• Ensure effective use of AI in validated, scalable, user-centric clinical trial processes.

Skills

Business analysis

Product analysis

Product management

Leadership

Communication

English fluency

Agile SAFe

GenAI / LLM usage

Tools

Jira

Confluence

GenAI tools

Job description

Описание:

Astek provides IT services and consulting. The role supports a client in the life sciences industry.

Задачи:

Collaborate with the Product Manager to define the product vision, strategy, and roadmap, co-create the MVP scope, and plan subsequent releases Prioritize and develop the Product Backlog, considering business needs, technical debt, and compliance requirements Conduct business analysis throughout the product lifecycle Translate Clinical Data Management needs into product requirements, user stories, acceptance criteria, target processes, and workflows Define requirements for key platform features, including AI-driven discrepancy detection, Human-in-the-Loop (HITL), automated query generation, Medidata Rave integrations, rule libraries, monitoring, governance, and GxP auditability Connect business, technology, architecture, AI/ML, UX, and regulatory perspectives Build and develop best practices for business analysis, requirements engineering, and documentation Collaborate with Clinical Data Management SMEs, Data Science/AI, Engineering, Enterprise Architecture, Quality & Validation, and UX teams Ensure effective use of AI in validated, scalable, user-centric clinical trial processes

Требования:

• 10+ Years of experience in Business Analysis, Product Analysis, Product Management, or roles combining these areas


• At least 5 years of experience in Life Sciences, particularly Clinical Development, Clinical Data Management, or Clinical Trial Operations


• Experience creating and developing complex, scalable enterprise digital products


• Strong knowledge of clinical processes and data


• Good knowledge of architecture and technologies, particularly REST APIs, microservices architecture, data integrations, and system interoperability in cloud environments


• Knowledge of regulatory requirements and validation processes, particularly GxP, CSV/CSA, and 21 CFR Part 11


• Experience leading and mentoring Business Analysts


• Ability to collaborate with senior stakeholders and influence decisions without formal authority


• Strong communication skills and fluent written and spoken English


• Very good knowledge of Jira, Confluence, and Agile / SAFe


• Practical experience using GenAI / LLM tools to improve analytical work and create BA artifacts

Условия:

Wynagrodzenie: do 15 000 brutto/miesiąc, w zależności od posiadanego doświadczenia i kompetencji Długoterminowa współpraca Szkolenia techniczne, certyfikaty i podnoszenie kwalifikacji Mentoring Competence Center, udział w konferencjach oraz dzielenie się wiedzą i doświadczeniem Jasna ścieżka kariery Pakiet benefitów pracowniczych (Multisport, prywatna opieka medyczna, ubezpieczenie na życie) Przyjazną atmosferę pracy, imprezy integracyjne i spotkania team-buildingowe System rekomendacji i bonus do 7000 zl