Senior Clinical Project Manager or Project Manager II - Cell & Gene Therapy

Responsibilities

• Accountable for project delivery with regards to agreed time, scope, cost, and quality.
• Lead core project team(s) and facilitate team's ability to lead extended project team(s), ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders.
• Proactively identify and resolve conflicts as needed.
• Understand the project delivery strategy, costing assumptions and resulting budget for assigned project(s).
• Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
• Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, Fortrea and client requirements.
• Create and manage variance to required project plans. Per SOPs, implement and monitor progress against project plans and revise, as necessary.
• Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract.
• Define and manage project resource needs and establish succession plans for key resources.
• Trains and mentors PM Academy PCs in multiple areas of expertise.

Qualifications

• University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Minimum of seven (7) years of relevant clinical research experience in a pharmaceutical company/CRO, including at least two (2) years of full project management responsibility.
• Cell & Gene Therapy experience.
• Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
• Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access, and Power Point).
• Experience managing projects in a matrix and virtual environment.
• Excellent communication, planning, and organizational skills.
• Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
• Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
• Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
• Financial awareness and ability to actively utilize financial tracking systems.
• Good knowledge of project management processes.
• Ability to work independently and mentor junior project team members.
• Ability to negotiate and liaise with clients in a professional manner.
• Ability to present to staff at all levels.