Global Project Manager

System One, Inc.; Oro Valley (AZ); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Job summary

System One, Inc. is seeking a Global Project Manager for Personalized Healthcare in Oro Valley, AZ. This 12-month contract role focuses on CDx development projects, with hybrid on-site work (~2 days/week) and a detailed plan-to-launch responsibility across budgets, schedules, and resources.

You will coordinate with pharma partners, manage scope and risks, and ensure quality within QMS guidelines. Experience in regulated settings and SAFe is highly valued.

Qualifications

• Bachelor’s degree in Life Sciences or closely related field.
• 4 years of experience in project management / engineering / business in diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects.
• At least one year in clinical biomarker or In Vitro Diagnostic development, CDx development, validations, regulatory submissions, instrument development, or program management.
• One year in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).
• Working knowledge of agile practices and SAFe; experience in hybrid Waterfall-Agile environments.
• Project Management Professional (PMP) and/or SAFe certifications beneficial.

Responsibilities

• Drive CDx development projects from conception to launch in collaboration with pharmaceutical partners.
• Own schedule creation and management using tools like Planisware; manage critical path and dependencies.
• Collaborate with functional leaders to identify resource needs and optimize allocations.
• Drive project budgets from scoping through post-contract execution and track expenditures.
• Define objectives and manage scope, changes, and impact assessments.
• Lead stakeholder and partner communications; ensure milestones are met and issues resolved.
• Identify risks, develop mitigation plans, and report to stakeholders.
• Ensure QMS compliance and drive continuous improvement and data quality.
• Coordinate with external partners; track milestones and forecast invoices.
• Apply appropriate project methodologies including hybrid Agile and SAFe; oversee WBS and milestones.

Skills

Project management

Cross-functional leadership

Agile/Scrum

Communication

Stakeholder management

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

Ph.D. in Life Sciences

Tools

Planisware

MS Office

Google Suite

Trello

LucidChart

Smartsheet

Jira

Azure DevOps

Job description

Job Title: Global Project Manager- Personalized Healthcare

Location: Oro Valley, AZ

Work Model: Hybrid - ~2 days/week on-site

Compensation: $62.00/hr

Type: 12-month contract, Potential for extension or conversion to permanent

Overview

As part of the Project Management Chapter, the Global Project Manager (GPM) plays a key role in optimized product delivery and is accountable for all project management aspects of various projects from simple to complex in nature. The GPM drives the project from the original concept through completion by developing and directing detailed work plans, schedules, project estimates, spending, resource plans, and status reports. As a trusted advisor, the GPM translates and drives projects into products and enables the organization to use energy and time effectively and efficiently while quickly responding to changing business needs across the portfolio.

Responsibilities

• Companion Diagnostics (CDx) Project Ownership: You will proactively drive, from conception to launch, the development activities for CDx Development projects in close collaboration with third-party Pharmaceutical partners.

• Schedule Management: You will proactively own timeline creation and management during scoping and post-contract execution using industry-standard tools such as Planisware. You will analyze the project critical path to determine priorities and drive team discussions, resolve dependencies and roadblocks, and guide the team to achieve key CDx contract deliverables.

• Resource Management: You will collaborate with project team members and key functional stakeholders to identify project resource needs, align functional leaders on resource availability, and continuously monitor usage and performance to optimize team allocation and proactively eliminate concerns.

• Budget Management: You will drive the project budget from initial scoping through post-contract execution. You will perform regular monitoring and maintenance of the budget with key functional stakeholders, prepare exception analyses for business and finance stakeholders, and track FTEs and project expenditures.

• Scope & Change Management: You will define project objectives and establish scope baselines. You will proactively identify and address any deviations in scope, budget, timeline, and resources using our change management process, and conduct comprehensive impact assessments. You will review Pharma-driven change requests with senior project stakeholders to determine if project contract amendments are necessary.

• Stakeholder & Communication Management: You will own project team meetings amongst internal members as well as with Pharma partners to ensure the delivery of CDx contract milestones. You will partner with the project team to engage stakeholders through appropriate channels, resolve conflicts, and secure acceptance from key project stakeholders

• Project Risk Management: You will proactively identify, evaluate, and prioritize project risks, engaging stakeholders to co-develop mitigation strategies and contingency plans. You will regularly review risks with your project team, and provide comprehensive risk reports to stakeholders to ensure informed decision-making.

• Quality Management & Project Health: You will partner with Quality stakeholders to ensure project execution is in compliance with our Quality Management System (QMS) framework and regulatory guidelines. You will conduct lessons learned activities to drive continuous improvement and provide insights for future projects. You will maintain high project data quality to enable teams to recognize recurring issues, pinpoint their root causes, and promote ongoing learning and process optimization.

• Partner & Vendor Management: You will facilitate effective collaboration, information flow, and decision-making with external Pharma entities. You will ensure all contract milestones are accurately tracked and status communicated to key internal stakeholders. You will own the communication of invoice forecasts to Pharma partners.

• Methodology & Execution: You will select and apply appropriate project methodologies, including hybrid Agile practices and Scaled Agile Framework (SAFe) where applicable. You will manage WBS creation and closeout, oversee milestone and capacity reviews, and act as a trusted advisor with a 360° view to support holistic planning and optimized value delivery.

• Other duties as assigned by leadership.

  Qualifications

  Required

• You hold a Bachelor’s degree, preferably in a Life Sciences field.

• You have 4 years of experience in project management / engineering / business in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects.

• You have at least one year of experience in the following areas: clinical biomarker or In Vitro Diagnostic development, CDx development, analytical and clinical validations, regulatory submissions, instrument/systems development, or program management.

• You have one year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).

• You are proficient and have demonstrated experience using Planisware, MS Office, and Google Suite, and “know-how” of project management tools such as Trello, LucidChart, Smartsheet, Jira, Azure DevOps, etc.

• You have working knowledge on Agile best practices and Agile-at-Scale methodologies (e.g SAFe), and have experience operating in hybrid Waterfall-Agile environments.

  Preferred:

• You hold a Master's degree, preferably in a Life Sciences field, and 6 years project management / engineering / business experience in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects. Alternatively, you hold a Ph.D with 3 years project management experience in those areas.

• You have 3 years of clinical biomarker or In Vitro Diagnostic development experience in CDx development, analytical and clinical validations and regulatory submissions or instrument development and program management.

• You have significant experience managing complex project team structures, including third-party external co-development partners.

• You have Project Management Professional (PMP) and/or SAFe Agile certifications.

  System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

  System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

  #LI-AD2

  Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.