Clinical Project Manager II, Phase I

Our Phase I team is seeking an Clinical Project Manager II to join our growing team. This role requires 2+ years of global project management experience, with preferred experience in phase I. Candidates must be based in the United States.

Job Overview:

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. Project Managers will work to develop and lead high performing teams by collaborating with key stakeholders to manage all aspects of the end-to-end lifecycle of the project including scope, timelines, risk, and budget. 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 in the creation of clear, data driven strategies and proactive management of project scope, timelines, quality, and budget. In collaboration with relevant departments, 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. Appropriately utilize data sources, dashboards, and risk management strategies to drive innovation and proactive problem solving with the project and client teams. Lead the adherence to project governance and issue escalation pathways, ensuring that project plans are in place to address identified risk while adhering to professional standards, SOPs, client, and regulatory requirements.

• 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. Ensures 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. Facilitating communication and teamwork while driving delivery, ensuring that team members understand contracted scope, timelines, and budget. Ensures that resource projections are accurate and visible to resourcing teams, proactively escalating resource constraints and challenges. Develops and mentors team members in multiple areas of expertise and provides feedback as needed to respective line managers.

• All other duties as needed or assigned.

Qualifications (Minimum Required):

• 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.

Experience (Minimum Required):

• 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 Phase I studies

• In lieu of the above requirement, candidates with (a) six (6) years supervisory experience in a heath care setting and (b) five (5) years clinical research experience including one (1) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries 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