[Remote] Risk based monitoring//Clinical project manager

Note: The job is a remote job and is open to candidates in USA. EROS Technologies Inc is seeking a Senior Project Manager / Business Analyst to lead business analysis and project delivery for Risk-Based Monitoring initiatives. The role coordinates clinical stakeholders and technical teams, supports RBQM configuration and rollout, and helps ensure clinical processes meet quality and regulatory expectations.

Responsibilities

• Lead end‑to‑end requirement gathering for RBM/RBQM initiatives, including Risk Indicators (KRIs), quality tolerance limits (QTLs), centralized monitoring workflows, and reporting needs
• Translate Clinical Operations needs into clear BRDs, FRDs, user stories, acceptance criteria, and traceability matrices
• Act as a clinical SME, ensuring alignment with protocol requirements, monitoring strategies, and regulatory expectations
• Facilitate workshops, design sessions, and stakeholder reviews across ClinOps, Data Management, QA, and IT teams
• Own day‑to‑day project management, including scope, schedule, dependencies, risks, and communication
• Drive delivery planning, sprint coordination, milestone tracking, and release readiness
• Manage dependencies across vendors, internal IT teams, and clinical stakeholders
• Provide regular executive‑ready status updates, risk assessments, and mitigation plans
• Support configuration and rollout of RBQM/RBM capabilities (e.g., centralized monitoring dashboards, risk signals, and alerts)
• Partner with Clinical Quality and Monitoring teams to ensure inspection‑ready RBM processes
• Ensure alignment with ICH E6(R2/R3), GxP, and 21 CFR Part 11 requirements
• Support validation deliverables and audit responses as needed
• Collaborate with development and QA/UAT teams to validate requirements and support test planning and execution
• Review test scenarios, scripts, and outcomes to ensure clinical and operational accuracy
• Support change management, training materials, and user enablement

Skills

• 8+ years overall experience as a Business Analyst and/or Project Manager in the clinical domain
• 5+ years hands‑on experience in Clinical Operations, including Risk‑Based Monitoring / RBQM
• Strong working knowledge of CTMS, RBQM tools, EDC, eTMF
• Proven experience creating BRDs, user stories, workflows, data mappings, and acceptance criteria
• Strong understanding of clinical trial lifecycle, monitoring strategies, and inspection readiness
• Experience working in Agile/Scrum environments (Jira, Azure DevOps)
• Ability to operate independently in a US‑remote, onshore‑facing role
• Veeva preferred

Benefits

• US-remote role

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