Title: Senior BA
Location: NJ / Remote
JD
User Research
Design and facilitate user interviews and focus sessions with clinical operations stakeholders including clinical research associates, study managers, and site activation leads to capture end-user needs and pain points.
Process Mapping
Create detailed as-is and to-be process maps covering clinical trial lifecycle activities such as site identification, feasibility, regulatory submissions, site activation, and patient enrollment workflows.
Requirements
Produce high-quality business requirements documents (BRDs), functional specifications, user stories, and acceptance criteria, ensuring traceability from business need through to system delivery.
UAT
Lead and coordinate user acceptance testing (UAT) activities including test script development, defect triage, and sign-off management, ensuring solutions meet clinical operations business requirements prior to go-live.
CTMS
Apply hands-on experience with Clinical Trial Management Systems (CTMS) to support configuration, enhancement, and adoption initiatives contributing deep knowledge of trial tracking, milestone management, and site-level data workflows.
Study Start-up
Bring subject-matter expertise in study start-up processes including site qualification, essential document collection, IRB/EC submission tracking, and country-level activation timelines to drive accurate requirements and process design.
Clinical Ops
Leverage a strong background in clinical operations (ClinOps) to bridge the gap between field-level trial execution realities and technology platform capabilities, ensuring solutions are operationally viable for sponsor and CRO teams.
Gap Analysis
Conduct gap analyses between current-state clinical operations processes and the target-state BeOne platform capabilities, clearly articulating business impact, risk, and recommended prioritization for each identified gap.
Change Management
Support change management and user adoption efforts by developing training materials, quick reference guides, and communication collateral tailored to clinical operations audiences across sponsor and site teams.
Agile Delivery
Work within an agile or hybrid delivery framework, participating in sprint planning, backlog grooming, and retrospectives acting as the voice of the clinical operations business throughout iterative development cycles.
Governance
Maintain rigorous documentation standards in alignment with Google Cloud Platform guidelines and internal governance requirements, ensuring all business analysis artefacts are audit-ready and version-controlled throughout the project lifecycle.