Clinical Project Manager

Glaukos Corporation • Aliso Viejo, CA

2d

About The Position

What You'll Do: The Project and Portfolio Management group is responsible for managing new product development and special initiatives to support corporate objectives. The Project Manager is responsible for managing projects from initiation through regulatory submission. Projects could include pharmaceutical, device and combination products across the retinal, corneal and glaucoma franchises. The individual will work closely with project leadership and cross-functional stakeholders to facilitate the development of project strategy, integrated project plans and implementation of those project plans to meet defined objectives. Key accountabilities include creation and maintenance of timelines, oversight and maintenance of budgets, and oversight of timely execution of activities. The individual will establish and maintain functionally integrated project timelines and will prepare and manage project team budgets in collaboration with Finance and the cross functional team leads. Responsibilities The Project and Portfolio Management group is responsible for managing new product development and special initiatives to support corporate objectives. Projects could include pharmaceutical, device and combination products across the retinal, corneal and glaucoma franchises. The Clinical Project Manager is part of this group and will work closely with the Clinical Development and Clinical Operation’s teams, ensuring seamless coordination, integrated project plans and implementation of those project plans to meet defined objectives Key accountabilities include oversight of integrated project timelines, establishing and maintaining clinical study metrics to aid strategy development and decision making. Support clinical teams with the development of project plans, timelines, and resource allocation for clinical trials and related activities Facilitate cross functional strategic discussions to ensure all elements of applicable clinical development are planned and executed Collaborate with cross-functional teams to ensure alignment with organizational goals. Create and maintain clinical studies metrics that will aid decision making and identify bottlenecks Helps to identify and manage risks, assisting in the development of proactive mitigation strategies Communicate transparently and in a concise fashion to relevant stakeholders regarding clinical study status, plans, risks and strategy Exercise excellent judgment in determining appropriate project communications to internal and external stakeholders Proactively identifies critical path constraints and works with R&D management to identify solutions Promote implementation and cross functional adoption of “fit for purpose” PMO tools, including MS Project, consistent use of SharePoint, and reporting and analytics tools Promote implementation and cross functional adoption of project management best practices and assist with training and development supporting the implementation of the organization’s PMO Contribute to the development and refinement of project management processes, tools, and best practices within the clinical development and operations teams

Requirements

• Bachelor’s Degree Required
• 5 plus years of project management experience in clinical research, clinical operations, or relevant medical device/pharmaceutical settings.
• Project management experience supporting complex projects, particularly management of clinical studies from strategy development to full execution
• Experience facilitating cross-functional team meetings to enable communication, decision-making, and alignment with internal and external stakeholders while managing project scope, deliverables, risks, and resources
• Experience in successfully working on multiple clinical studies in the pharmaceutical space that required strong organizational, analytical, and problem-solving skills
• Knowledge of pharmaceutical clinical study development processes and deliverables at each stage of the pipeline, with a focus on IND enabling studies through clinical proof-of-concept, pivotal clinical and regulatory submission
• Knowledge of clinical trial processes, GCP, and regulatory requirements (FDA, EMA, etc.).
• Comfort working in an innovative and entrepreneurial environment; operates well with ambiguity and proactively identifies and actions solutions
• Strong project management skills required, including attention to detail and organization skills
• Ability to work cross functionally and collaboratively to develop and execute development plans
• Adaptability to shifting strategies or changing project priorities
• High level of communication skills including written and verbal platforms
• Expertise in project management tools including Microsoft Project, Excel, SharePoint and PowerPoint

Nice To Haves

• Tableau or other BI tool experience preferred

Responsibilities

• creation and maintenance of timelines
• oversight and maintenance of budgets
• oversight of timely execution of activities
• establishing and maintaining clinical study metrics to aid strategy development and decision making
• Support clinical teams with the development of project plans, timelines, and resource allocation for clinical trials and related activities
• Facilitate cross functional strategic discussions to ensure all elements of applicable clinical development are planned and executed
• Collaborate with cross-functional teams to ensure alignment with organizational goals.
• Create and maintain clinical studies metrics that will aid decision making and identify bottlenecks
• Helps to identify and manage risks, assisting in the development of proactive mitigation strategies
• Communicate transparently and in a concise fashion to relevant stakeholders regarding clinical study status, plans, risks and strategy
• Exercise excellent judgment in determining appropriate project communications to internal and external stakeholders
• Proactively identifies critical path constraints and works with R&D management to identify solutions
• Promote implementation and cross functional adoption of “fit for purpose” PMO tools, including MS Project, consistent use of SharePoint, and reporting and analytics tools
• Promote implementation and cross functional adoption of project management best practices and assist with training and development supporting the implementation of the organization’s PMO
• Contribute to the development and refinement of project management processes, tools, and best practices within the clinical development and operations teams

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees