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Project Manager - IVD (ADX-156-20)

Company: ArcherDX, Inc.
Location: Boulder
Posted on: June 8, 2021

Job Description:

Project Manager - IVD (ADX-156-20)COMPANY SUMMARY: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 . POSITION SUMMARY:The Project Manager will provide project management leadership and expertise to enable the organization to meet business objectives. This individual will centrally 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. The selected candidate will lead projects throughout the entire lifecycle of initiation, planning, execution, monitoring & control, and closing under the leadership directive of the General Manager and Program Manager. The Project Manager will engage subject matter experts and functional leaders to develop integrated project plans, identify stakeholder requirements, and balance competing project constraints of scope, quality, schedule, budget, resources, and risk.RESPONSIBILITIES:Job performance will involve a variety of activities including: (26 12) Ensure projects are delivered on time through initiation, planning, execution, monitoring/control, and closure by providing sound project management expertise and coaching Facilitate issue and risk communication and management in collaboration with the project/program teams. Document key project decisions, facilitate information management processes, and provide data-driven summaries of project status Implement processes to manage and control all types of project change Address the needs, concerns, and expectations of all stakeholders through active and collaborative communication Support the implementation of standard project and business management processes and tools. These processes and tools may include the development, monitoring, and control of integrated timelines, budgets, risk management plans, communication plans, and business process maps. Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures. Safeguarding the privacy and security of protected health information and European Union personal data. Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures. Safeguarding the privacy and security of protected health information and European Union personal data. Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology. EXPERIENCE: Demonstrated knowledge of project management skills, tools, and processes in areas such as timeline, cost, and risk management. Proficiency with standard project management and enterprise resource planning software. Experience with design control for medical device development, preferably diagnostic assays. Experience with clinical trials within a biotechnology, pharmaceutical or biopharmaceutical company preferred. Understanding on 510k and PMA diagnostic approval process from concept to submission. Must have experience operating at the individual project level for organizational project management. Minimum of 5 years' experience in the diagnostic or pharmaceutical industry. Proven ability to coordinate multifaceted projects, including multitasking, deliverables management and timeline management. Demonstrate ability to work within a commercial environment and influence with and without authority in a cross functional role. Experience in diagnostic development or similar development paradigm KEY ATTRIBUTES: High energy, self-motivated, approachable, and articulate team player Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company Excellent oral and written communication tailored to specific audiences Ability to influence without power Strong attention to detail, demonstrating accuracy in tracking and reporting data Good problem-solving skills: able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence Independent self-management and organizational skills: able to manage workload, set personal and project priorities, and adjust as needed Flexibility to adjust quickly and effectively to frequent change and shifting priorities EDUCATION: BS/MS/PhD preferred with relevant training in Chemistry, Manufacturing, and/or Biological Sciences or equivalent experience. Project management certification (PMP, PRINCE2) or equivalent

Keywords: ArcherDX, Inc., Boulder , Project Manager - IVD (ADX-156-20), Other , Boulder, Colorado

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