Project Manager – IVD (Diagnostics) (ADX-44-21)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
The Project Manager will provide project management leadership and expertise for coordinating activities with two technical departments. This individual will manage one or more projects and apply project management knowledge, skills, tools, and techniques to project activities to meet project requirements and achieve desired outcomes. Will lead projects throughout the entire lifecycle of initiation, planning, execution, monitoring & control, Will engage subject matter experts to develop integrated project plans, identify stakeholder requirements, and balance competing project constraints of scope, quality, schedule, budget, resources, and risk.
May be a remote position.
- Ensure projects are delivered on time and risks associated with timelines/deliverables clearly communicated to management.
- Develop integrated project management plans and project schedules through the use of progressive elaboration
- Document key project decisions and facilitate information management processes
- Prioritize team and physical resource allocations.
- Implement processes to manage and control all types of project change
- Lead project team meetings, develop agendas, follow-up on action items
- Support project teams through the initiation, planning, execution, monitoring/control, and closing of their projects by providing sound project management expertise and coaching.
- Facilitate issue and risk management in collaboration with the project/program teams.
- Support the implementation of standard project and business management processes and tools. These processes and tools may include the development, monitor, and control of integrated timelines, budgets, risk management plans, communication plans, and business process maps.
- Generate or integrate project specific metrics/reports and analyzing options and opportunities to optimize the project team’s productivity.
- Collect data for and prepare accurate management of governance committee updates on project status using appropriate templates and tools.
- Establish, maintain and use information repositories and collaboration sites.
- Effectively communicate project status to external pharma partners throughout the development process
- Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology
- 5 years' experience in the diagnostic or pharmaceutical industry.
- Project management certification (PMP®, PRINCE2®) or equivalent.
- Experience with design control for medical device development.
- Understanding on 510k and PMA diagnostic approval process from concept to submission.
- Understanding of clinical trial logistics and brining drug and diagnostic from concept to approval.
- Proficiency with standard project management software and enterprise resourcing planning.
- Significant experience with clinical trials within a biotechnology, pharmaceutical or biopharmaceutical company.
- Experience operating at the individual project level for organizational project management.
- Ability to travel up to 10% (post Covid)
- BS/MS/PhD preferred with relevant training in Chemistry, Manufacturing, and/or Biological Sciences, or equivalent experience.
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