Global CDx Project Manager – Personalized Healthcare

Spectraforce Technologies, Inc.; Tucson (AZ); Hybrid; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Spectraforce Technologies, Inc. is seeking a Global Project Manager to lead CDx development programs in the Personalized Healthcare Solutions portfolio.

The role supports hybrid work with on-site presence in the Oro Valley area, coordinating cross-functional teams and external Pharma partners to deliver projects from concept to launch. The position emphasizes strong project management practices, regulatory awareness, and effective communication across stakeholders.

Qualifikationen

• Bachelor's degree, preferably in a Life Sciences field.
• 4+ years of experience in project management/engineering/business in diagnostic, medical device, pharmaceutical or biotech industries.
• At least 1 year in areas such as CDx development, regulatory submissions or instrument development; experience in a regulated environment (FDA 21 CFR 820, ISO 13485, ISO 9001).
• Proficiency with Planisware, MS Office, Google Suite; familiarity with Jira, Trello, LucidChart, Smartsheet, Azure DevOps.

Aufgaben

• Drive CDx development projects from concept to launch in collaboration with pharma partners.
• Own schedule creation and management using Planisware; manage critical path and resolve roadblocks.
• Collaborate with stakeholders to identify resources and optimize team allocation.
• Oversee project budget from scoping through execution and track expenditures.
• Define scope baselines and manage deviations using change processes; assess impact of changes.
• Lead project team meetings with internal and partner stakeholders to ensure milestones are met.
• Identify risks, develop mitigation plans, and report to stakeholders.
• Ensure alignment with QMS and regulatory guidelines; capture lessons learned.
• Coordinate with external partners to support contract milestones and invoicing.

Kenntnisse

Project management

Hybrid Waterfall-Agile

SAFe Agile

Vendor management

Ausbildung

Bachelor's degree (Life Sciences preferred)

Tools

Planisware

MS Office

Google Suite

Trello

LucidChart

Smartsheet

Jira

Azure DevOps

Jobbeschreibung

Spectraforce Technologies, Inc. is seeking a Global Project Manager to lead CDx development programs in the Personalized Healthcare Solutions portfolio.

The role supports hybrid work with on-site presence in the Oro Valley area, coordinating cross-functional teams and external Pharma partners to deliver projects from concept to launch. The position emphasizes strong project management practices, regulatory awareness, and effective communication across stakeholders.