Sr Project Manager

Job Summary
Job Description
This role will be responsible for budget tracking, forecasting, and other financial analysis for a complex program of R&D initiatives across the QA, clinical, regulatory, and laboratory areas. The successful candidate must develop relationships with both IT and R&D stakeholders to track project actuals, report overall progress, and mitigate risks across projects. Experience working with and supporting executive leadership is critical. This role demands the ability to align program direction with organizational strategic goals and work closely with business stakeholders to ensure on-time/on-budget project delivery.

Key Accountabilities/Core Job Responsibilities:

• Substantial experience tracking and reporting project financial metrics, including plan versus actuals, forecasting, ROI estimation, and TCO calculation
• Deep knowledge of bottoms-up capital and operational budgeting, contract structures, tracking, and partnering with fix assets team
• Development of financial analysis, budget forecasts, and presentation material for consumption by executive leadership
• Experience leading and driving organizational alignment efforts within a technology function
• Ability to plan and manage complex programs governed by GxP processes, computer system validation, 21 CFR Part 11, and other FDA regulations
• Independently coordinate with vendor and in-house programmer/administrator staff
• Organize, schedule, and lead in-person and web-based meetings with authority, in professional manner.
• Coordinate and adjust meetings and communications involving stakeholders and project participants across North American time zones
• Author project documentation including Business Justification, Project Proposal, Project Charters, Budget Tracker, Schedule, Status Dashboard, Timeline visuals, Lessons Learned
• Pro-actively lead requirement gathering efforts and coordinate with business SMEs, IT architect, IT Business Analysts, Developers, Validation Team to translate information into Functional and Technical requirements specifications.
• Professionally prepare presentations for IT and business executives, including strategic roadmaps, budget analyses, and operational plans
• Maintain organized, clear, focused project schedule and status to ensure project success.
• Escalate issues to Sr. Management and to vendor support as needed

Qualifications, Experience and Education Requirements:

• 7-10 years of experience building project budgets that include both capital and operational spend
• 7-10 years of experience managing projects to implement system/s in GxP controlled environment including responsibility for the implementation of R&D systems
• Extensive experience developing, managing, and reporting on capital and operational budgets
• Strong interpersonal and communication skills; ability to interact with different levels of management.
• Project management in the Bio-Pharma, Life Sciences industry is required.
• Skills: Project Management, SDLC, Business Analysis, Vendor Management, Computer Systems Validation.
• Expertise in Microsoft Office applications, especially Excel and PowerPoint.
• Pharma systems experience in QA, clinical, laboratories, and/or regulatory is a plus.
• BA or BS degree in technical or scientific discipline required.
• PMP certification.

Job Type: Contract

Experience:

• Project Management: 7 years (Preferred)