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Senior IT Project Manager
Reporting To: Global Head of Clinical R&D IT / Platform Lead
Role Summary
Senior IT Project Manager to lead global Clinical R&D technology initiatives from planning through validated implementation and operational handoff, with accountability for scope, schedule, budget, quality, risk, resources, and compliance.
The resource will partner with business, IT, Quality, Validation, Security, Architecture, and vendors while providing governance, executive reporting, and timely escalation.
Ideal profile: Senior project leader with pharmaceutical, biotechnology, or CRO experience delivering regulated clinical systems, data platforms, cloud solutions, integrations, migrations, or upgrades.
Scope of Responsibilities
1. Project Delivery and Execution
Lead global, multi-workstream Clinical R&D IT projects through validated implementation and operational transition.
Maintain charters, integrated plans, schedules, budgets, resources, risks, issues, decisions, dependencies, and acceptance criteria.
Control scope, timeline, cost, quality, benefits, and delivery commitments; coordinate technical workstreams and corrective actions.
2. Strategy, Governance, and Business Alignment
Define project outcomes, roadmap, governance, success measures, and delivery structure with business and IT leaders.
Lead steering committees and decision forums; provide concise reporting on progress, financials, risks, issues, dependencies, and benefits.
Maintain alignment with Clinical R&D priorities, technology strategy, compliance, and operational objectives.
3

Stakeholder, Vendor, and Team Leadership
Serve as the primary contact and escalation point for sponsors, stakeholders, IT teams, quality partners, and vendors.
Lead cross-functional teams and global project forums; drive accountability and timely decisions.
Manage vendors, contractors, contracts, statements of work, milestones, service levels, quality, and acceptance criteria.
4. Compliance, Risk, Financial, and Change Management
Ensure delivery meets GxP, CSV, data integrity, security, SDLC, change control, testing, traceability, release, and SOP requirements.
Manage project, compliance, financial, vendor, resource, dependency, and operational risks.
Track budgets, forecasts, spend, funding, and resource utilization.
Support communication, training, adoption, transition, and audit-ready documentation.
Candidate Requirements
Education and Experience
Bachelor's degree in IT, Computer Science, Life Sciences, Engineering, Business, or a related field.
15+ years of professional experience, including 10+ years managing complex IT projects in pharmaceutical, biotechnology, or CRO environments.
Demonstrated experience leading global regulated Clinical R&D system implementations, migrations, upgrades, integrations, or modernization programs.
PMP preferred; Agile, Scrum, SAFe, or equivalent certification is a plus.
Industry and Technical Knowledge
Strong knowledge of Clinical R&D processes, clinical data flows, and the clinical technology landscape.
Working knowledge of GAMP 5, GCP, GDP, GDPR, 21 CFR Part 11, CSV, data integrity, SDLC, and release governance.
Experience with Waterfall, Agile, and hybrid delivery; cloud, data, infrastructure, cybersecurity, and integration concepts.
Strong executive reporting, business case, portfolio, resource, budget, and project planning skills.
Core Competencies
Executive communication and stakeholder influence
Strategic thinking and business acumen
Risk management and problem solving
Accountability, collaboration, and change leadership
Expected Outcomes
Projects delivered within approved scope, schedule, budget, quality, and compliance expectations.
Effective governance, actionable reporting, and timely escalation.
Validated solutions delivered with inspection-ready documentation and a sustainable operational transition.