Senior Project Manager -- (RMB/Risk Based Monitoring/RBQM)

Role SummaryWe are seeking a Senior Project Manager 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 ResponsibilitiesBusiness Analysis & Clinical Domain LeadershipLead end‑to‑end requirement gathering for RBM/RBQM initiatives, including Risk Indicators (KRIs), quality tolerance limits (QTLs), centralized monitoring workflows, and reporting needsTranslate Clinical Operations needs into clear BRDs, FRDs, user stories, acceptance criteria, and traceability matricesAct as a clinical SME, ensuring alignment with protocol requirements, monitoring strategies, and regulatory expectationsFacilitate workshops, design sessions, and stakeholder reviews across ClinOps, Data Management, QA, and IT teamsProject & Program ManagementOwn day‑to‑day project management, including scope, schedule, dependencies, risks, and communicationDrive delivery planning, sprint coordination, milestone tracking, and release readinessManage dependencies across vendors, internal IT teams, and clinical stakeholdersProvide regular executive‑ready status updates, risk assessments, and mitigation plansRisk‑Based Monitoring FocusSupport 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 processesEnsure alignment with ICH E6(R2/R3), GxP, and 21 CFR Part 11 requirementsSupport validation deliverables and audit responses as neededDelivery & Quality SupportCollaborate with development and QA/UAT teams to validate requirements and support test planning and executionReview test scenarios, scripts, and outcomes to ensure clinical and operational accuracySupport change management, training materials, and user enablementRequired Experience & Skills8+ years overall experience as a Business Analyst and/or Project Manager in the clinical domain5+ years hands‑on experience in Clinical Operations, including Risk‑Based Monitoring / RBQMStrong working knowledge of CTMS, RBQM tools, EDC, eTMF (Veeva preferred)Proven experience creating BRDs, user stories, workflows, data mappings, and acceptance criteriaStrong understanding of clinical trial lifecycle, monitoring strategies, and inspection readinessSecondary / Good‑to‑Have SkillsFamiliarity with Veeva Vault Clinical (CTMS, Quality, CDMS) and RBQM modulesKnowledge of centralized monitoring analytics, data visualization, and operational dashboardsExperience supporting CSV/validation documentationStrong Excel and data analysis skills for monitoring metrics and reportsExposure to vendor oversight and multi‑partner delivery models