Product Owner/ Sr. Business Analyst
Platform Engineering & Clinical data, Trial data, clinical trials Phase 1-3
We are looking for a skilled and proactive Product owner to support and lead a team of Engineers delivering scalable, cloud-native solutions in the Healthcare domain. This role is focused on projects involving clinical trial data, requiring a deep understanding of Clinical trials (Phase 1-3) workflows, data standards, and compliance. The ideal candidate will have experience working with modern clinical platforms, cell therapy context including patient journey mapping, chain of identity/custody, and TRiSP processes; and the ability to bridge business needs with technical execution. Plus, will lead the product lifecycle and prioritization for the orchestration system and similar clinical trial and therapeutics systems. He will act as the bridge between stakeholders, engineering, QA, and end-users (clinicians, coordinators). Responsible for value delivery aligned with cell therapy, drug development and testing, audit reporting, clinical data reporting workflows.
Requirements
* 7+ years of experience as a Business Analyst or Product Owner working with healthcare clinical data.
* Strong domain expertise in clinician-side and trials side processes.
* Understanding of HIPAA and best practices for managing PHI/PII in healthcare data environments.
* Familiarity with FHIR, HL7, and healthcare data integration standards.
* Experience developing detailed requirements documentation, data dictionaries, and system/process diagrams.
Nice-to-haves
* Hands-on experience with data validation and profiling for large-scale claims datasets.
* Exposure to GCP, AWS, Azure, or and their native data services.
* Familiarity with both trials and clinical data models and their integration
* Experience with BI/reporting tools such as Power BI, Looker, or Tableau.
* Bachelor's or Master's degree in Healthcare Informatics, Information Systems, or a related field.
Core Responsibilities
* Act as a liaison between business stakeholders and the Data Engineering team, translating complex clinical data requirements into actionable development tasks.
* Lead discovery and requirements workshops focused on operations, data intake, chain of custody and other related processes.
* Document end-to-end data flows, business logic, data mapping, and acceptance criteria for ingestion, transformation, and reporting of trial related data.
* Own and maintain the product backlog, grooming epics and user stories.
* Prioritize features based on patient journey insights and commercial scalability.
* Engage with cross-functional stakeholders (clinical ops, QA, regulatory, sites).
* Drive agile ceremonies: sprint planning, reviews, retrospectives.
* Translate regulatory and CoI/CoC needs into technical requirements.
* Align product vision with roadmap and commercialization/ Research goals.
* Define success KPIs (e.g., scheduling efficiency, alert accuracy).
* Oversee user research, prototyping, and usability assessments.
* Ensure integration with EMR, LIMS, EDC, and drug manufacturing, supply chain systems.
* Track product progress and adjust roadmap based on feedback and pilots.
* Design role-based access control and user provisioning workflows.
* Implement audit trail monitoring and exception logging.
* Review and enforce HIPAA, GDPR, and 21 CFR Part 11 requirements.
* Conduct security risk assessments and pen testing coordination.
Soft Skills
* Excellent communication skills, both written and verbal, with the ability to work across business and technical teams.
* Strong problem-solving skills and attention to data accuracy.
* Self-starter with the ability to lead initiatives with minimal oversight.
* Passion for improving healthcare operations through better data and technology.
Why Join Us?
* Influence data-driven decision making in healthcare with real-world impact.
* Work on modern cloud platforms (Google Cloud, Databricks/Snowflake, AWS, etc.).
* Join a team of high-performing engineers and healthcare data experts.
* Thrive in a flexible, collaborative, and mission-driven environment.
What We Offer
* Continuous learning and career growth opportunities
* Professional training and English/Spanish language classes
* Comprehensive medical insurance
* Mental health support
* Specialized benefits program with compensation for fitness activities, hobbies, pet care, and more
* Flexible working hours
* Inclusive and supportive culture
About Us
Established in 2011, Trinetix is a dynamic tech service provider supporting enterprise clients around the world.
Headquartered in Nashville, Tennessee, we have a global team of over 1,000 professionals and delivery centers across Europe, the United States, and Argentina. We partner with leading global brands, delivering innovative digital solutions across Fintech, Professional Services, Logistics, Healthcare, and Agriculture.
Our operations are driven by a strong business vision, a people-first culture, and a commitment to responsible growth. We actively give back to the community through various CSR activities and adhere to international principles for sustainable development and business ethics.
To learn more about how we collect, process, and store your personal data, please review our Privacy Notice: #J-18808-Ljbffr