Operations & Project Management

Clinical Project Manager with BA background

Anagha Techno SoftFoster City, CA🇺🇸United StatesPosted Oct 20, 2026

Quick Overview

Seniority

Mid Senior

Work mode

Hybrid

Location

Foster City, CA, United States

Posted

Yesterday

Stakeholder ManagementMicrosoft ExcelScrumBusiness AnalysisJiraAgileProject ManagementData Analysis

Job Description

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