Global CDx Project Manager (Hybrid | Contract)

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

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.