Project Manager with BA

Role:

Senior Project Manager / BA with

Clinical Operations Location:

Foster City, CA -

Onsite Employment Type:

Fulltime Max Salary:

$145K/Annum + Benefits Role Summary 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 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 What Success Looks Like Well defined, regulator ready RBM requirements with minimal rework Strong stakeholder confidence in monitoring strategy and system implementation On time delivery of RBM initiatives with clear visibility into risks and outcomes Seamless coordination between Clinical, Quality, and IT teams High quality documentation supporting audits and inspections Why Join This Engagement High visibility Clinical Operations & RBM program at a leading life sciences organization Opportunity to influence modern, risk based clinical trial execution Exposure to enterprise Veeva and RBQM platforms Strategic role combining clinical insight, BA rigor, and project leadership