CTMS (Clinical Trial Management System) Project Manager

We are seeking a Senior Project Manager / Business Analyst with deep Clinical Operations expertise and hands‑on experience in Risk‑Based Monitoring (RBM/RBQM) initiatives. This role combines strong business analysis capabilities with program/project management ownership, supporting enterprise‑scale clinical systems and processes.
The ideal candidate will independently manage stakeholder engagement, requirements definition, delivery coordination, and governance for RBM initiatives, working closely with Clinical Operations, Data Management, Quality, Biostats, and IT teams. Experience with CTMS, RBQM, EDC, and Veeva Clinical platforms is highly preferred.
Key Responsibilities
Business Analysis & Clinical Domain Leadership
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
Project & Program Management
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
Risk‑Based Monitoring Focus
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
Delivery & Quality Support
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
Required Experience & 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 (Veeva preferred)
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

Work arrangement
Yes