Clinical Project Manager II

Role Description

Our FSO team is seeking a Cell & Gene Therapy Clinical Project Manager to join our growing team. This role requires 2+ years of global project management experience, with experience in cell & gene therapy. Candidates must be based in the United States.

Project Managers own the operational strategy, determining the most cost effective and efficient means to successfully run and complete projects on time, while maintaining quality, remaining within budget, while meeting the customer’s needs and adhering to the contract. A successful Project Manager will bring innovation and future focused approaches to clinical trials with a focus on patient centricity and consistent solutions-oriented delivery.

Summary of Responsibilities

• Take accountability for proactively driving project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence.
• Take ownership of the customer relationship while drawing on the Company’s pool of experts.
• Drive communication and collaboration with the client and project team across a matrixed, multi-cultural environment.
• Lead the development of the project strategy and ensure prioritization with the project team and key stakeholders.
• Prepare and deliver presentations for new business as required.
• Lead the identification of project, financial and quality risk leveraging end to end risk management practices and quality by design principles.
• Utilize data sources, dashboards, and risk management strategies to drive innovation and proactive problem solving.
• Lead the adherence to project governance and issue escalation pathways.
• Partner with project team members and key stakeholders to oversee and manage project budgets, resources, and scope.
• Ensure adherence to established budget and financial milestones.
• Accountable for accurately forecasting project revenue and managing project costs in adherence to the budget.
• Leading the timely management of changes to scope and the change order process.
• Ensure project team awareness and tracking of KPIs for any client specific metrics.
• Provide inspiring leadership and play a key role in the creation of high performing project teams.
• Facilitate communication and teamwork while driving delivery.
• Ensure that resource projections are accurate and visible to resourcing teams.
• Develop and mentor team members in multiple areas of expertise and provide feedback as needed.
• All other duties as needed or assigned.

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.

Requirements

• Minimum of five (5) years of relevant clinical research experience in a pharmaceutical company/CRO.
• 2+ years of Clinical Project Management experience within a CRO or pharma company.
• Experience working on Cell & Gene Therapy studies.
• Experience working with Biotech clients.
• In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a health care setting and (b) five (5) years clinical research experience including one (1) years of project management experience will be considered.
• 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.
• 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.

Preferred Qualifications Include

• Master’s or other advanced degree.
• PMP certification.

Benefits

• Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:
• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers).
• 401(K).
• Paid time off (PTO) – Flex Plan.
• Employee recognition awards.
• Multiple ERG’s (employee resource groups).
• Target Pay Range (based on title): $125 - 135k.

Physical Demands/Work Environment

• Standard Office Environment or remote based work required.
• Weekend and off-hour work as required.

Travel Requirements

• Local, Domestic, Regional, Global.
• Identify the expected travel requirements of the position on an annual basis:
• % of time: up to 30%.
• % of the above that requires overnight stay: up to 30%.
• Travel is primarily to where: domestic and international travel.