Project Manager I, Ophthalmology

Fortrea is seeking an Ophthalmology Clinical Project Manager I to join their growing FSO team. The role involves owning the operational strategy for projects, managing timelines, risk, and budget, while ensuring quality and customer satisfaction in clinical trials.

Responsibilities:

• Assist in the leadership of the core project team, as directed by team leadership to facilitate their ability to lead extended cross-functional project teams
• Assist in the successful design, implementation, tracking and maintenance of project plans for assigned projects
• Assist in ensuring that all staff allocated to assigned projects adheres to professional standards and SOPs
• The Project Manager will take accountability for driving project performance while meeting customer needs and maintaining operational excellence
• This includes the maintenance of timelines and tracking project progress against contracted deliverables
• Under the direction of team leadership, proactively lead quality control and risk assurance activities to ensure project deliverables are met according to regulatory, internal, and client requirements
• Participate in the identification, tracking and maintenance of projects, financial and quality risks using appropriate data sources, dashboards, and risk management strategies
• Adheres 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
• Fosters a positive client experience by serving as client primary contact for areas assigned by Project Leadership
• Engages in communication and collaboration with the client and project teams across a matrixed, multi-cultural, environment
• Participates in the development of project strategy in collaboration with relevant departments
• Assist project team members and key stakeholders to effectively manage budget, resources, and scope
• Participated in forecasting project revenue and managing project costs in adherence to the budget
• Assist in the management and tracking of project resource needs and contribute to contingency planning for key resources
• Ensures that resource projections are accurate and visible to resourcing teams, proactively escalating resource constraints and challenges
• Identify timely scope changes against contract to assist in the change order process
• Facilitates positive communication and teamwork
• Develops and mentors more junior team members and provides feedback as needed to respective line managers
• All other duties as needed or assigned

Requirements:

• 4+ years of global project coordination experience
• Mandatory experience in ophthalmology
• Candidates must be based in the United States
• 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
• In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements
• Minimum of three (4) years of relevant clinical research experience in a pharmaceutical company/CRO
• In lieu of the above requirements, candidates with greater than four (4) years supervisory experience in a health care setting of which two (2) years clinical research experience (including monitoring) 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
• Demonstrated experience managing or supporting ophthalmology clinical trials, with strong working knowledge of ocular indications, assessment methodologies, and retinal (posterior segment) disease
• Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access, and Power Point)
• Ability to work with minimal supervision
• Excellent verbal and written communication skills
• Ability to set clear expectations for junior staff on projects
• Ability to resolve project-related problems and prioritizes workload for self and team
• Demonstrated organizational skills and the ability to prioritize multi-tasks
• Ability to understand and work with financial information
• Basic knowledge of project management processes
• Demonstrated ability to work within a matrix system
• Local project coordination and/or project management experience
• Proven experience managing global clinical trials across multiple regions, with an understanding of cross-functional and cross-cultural considerations