Senior Project Manager

Role Summary

We 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 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

Secondary / Good‑to-Have Skills

• Familiarity with Veeva Vault Clinical (CTMS, Quality, CDMS) and RBQM modules
• Knowledge of centralized monitoring analytics, data visualization, and operational dashboards
• Experience supporting CSV/validation documentation
• Strong Excel and data analysis skills for monitoring metrics and reports
• Exposure to vendor oversight and multi‑partner delivery models