IT Project Manager - Senior

· Lead global, multi-workstream Clinical R&D IT projects from planning through validated implementation and operational handoff.

· Manage project scope, schedule, budget, resources, quality, risks, issues, dependencies, and vendors.

· Partner with Business, IT, Quality, Validation, Security, Architecture, and external vendors.

· Lead governance activities, steering committees, executive reporting, and timely escalation.

· Ensure projects meet GxP, CSV, data integrity, security, SDLC, testing, traceability, change control, and release requirements.

· Support successful delivery of regulated Clinical R&D systems, data platforms, cloud solutions, integrations, migrations, and upgrades., Project Delivery and Execution

· Lead global Clinical R&D IT projects through validated implementation and operational transition.

· Maintain project charters, plans, schedules, budgets, resources, risks, issues, decisions, dependencies, and acceptance criteria.

• Control project scope, timeline, cost, quality, benefits, and delivery commitments.

Strategy and Governance

· Define project outcomes, roadmap, governance, success measures, and delivery structure.

· Lead steering committees and decision forums.

• Provide executive reporting on project progress, financials, risks, issues, dependencies, and benefits.

Stakeholder and Vendor Management

· Serve as the primary contact and escalation point for sponsors, stakeholders, IT teams, Quality, and vendors.

· Lead cross-functional and global project teams.

• Manage vendors, contractors, contracts, SOWs, milestones, SLAs, quality, and acceptance criteria.

Compliance and Risk 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, spending, funding, and resource utilization.

• Support communication, training, adoption, transition, and audit-ready documentation.

• Bachelor’s degree in IT, Computer Science, Life Sciences, Engineering, Business, or a related field.

Skills

· 10+ years managing complex IT projects in pharmaceutical, biotechnology, or CRO environments.

· Experience with Clinical R&D systems and technology.

· Experience with system implementations, migrations, upgrades, integrations, or modernization programs.

· Knowledge of GAMP 5, GCP, GDP, GDPR, 21 CFR Part 11, CSV, data integrity, SDLC, and release governance.

· Experience with Waterfall, Agile, and Hybrid methodologies.

· Knowledge of cloud, data, infrastructure, cybersecurity, and integration concepts.

· Strong executive communication, stakeholder management, risk management, problem-solving, and project planning skills.

· PMP preferred; Agile, Scrum, SAFe, or equivalent certification is a plus.