Project Manager with BA
Aroha Technologies
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Job Details
Skills
- EDC
- User Stories
- Clinical Operations
- RBQM
- eTMF (Veeva preferred)
- CTMS
- BRDs
- workflows
- data mappings
Summary
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
- Dice Id: 10515154
- Position Id: 2026-6452
- Posted 16 hours ago
Company Info
About Aroha Technologies
Michael Arrington, founder and co-editor of Tech Crunch once famously said that ‘The best startups generally come from somebody needing to scratch an itch’.
Quite true to the thought, Aroha Technologies Inc was launched in 2008 in Florida. While we began our journey with a powerful Staffing Specialist & Software Development, Today our procedure has amplified into a more robust and simplified solution for Marketers looking for consistent and long term.
In our quest to do better, we resolve to simplify user acquisition, retention, engagement and large Business without blinking an eyelid! A semi-remote team spread across the globe, we are here to help you one step at a time.
Unmatchable growing excellence When AROHA was formed, we interviewed many potential clients and business colleagues and asked what a single important question seemed: “If you could design a firm to meet your needs, what would it look like?” The answers to that question have guided our thinking and planning on an ongoing basis, and form the core of our thinking about how we treat our clients and our employees, whom we call associates.
At a most basic level, we have stated our mission in a promise to our clients and our associates: “Unmatchable growing excellence.” This alignment governs superior service to our customers and supports our associates who perform that work, which cannot be matched by our competitors.
In short, we believe that care of our associates, disciplined financial management, and constant attention to the fundamentals of good delivery adds up to a successful, scalable business.
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