FSP - Clinical Team Lead - Ophthalmology - US

Fortrea•Durham, NC

22h•Remote

About The Position

Fortrea is seeking experienced Clinical Team Leads for its U.S.-based remote FSP team, specializing in ophthalmology. Clinical Team Leads own the clinical delivery of clinical research trials and function as the Clinical Project Manager within the core project team. They partner with the Project Manager and other functional leads to deliver the clinical aspects of trials within contractual and budgetary requirements, oversee clinical and site management, and represent clinical delivery with the customer. The role leads clinical project strategy and performance, collaborating with clients, project teams, stakeholders, and functional departments. It oversees project scope, timelines, quality, budgets, resources, risks, recruitment and retention, vendor delivery, monitoring strategy, and applicable regulatory and ethics committee activities. The Clinical Team Lead also supports business development and bid defenses, and provides leadership, mentoring, and guidance to project team members. The position is remote-based or in a standard office environment, with up to 30% global travel, primarily domestic and international. Weekend and off-hour work may be required.

Requirements

University or college degree, preferably in life sciences, or certification in a related allied health profession from an appropriately accredited institution; relevant equivalent experience may be considered in lieu of education requirements.
Bachelor’s degree.
At least 5 years of clinical research or monitoring experience, or an equivalent combination of education and experience to perform the job’s key responsibilities.
At least 3 years of experience leading project teams through study start-up, conduct, data management, analysis, closeout, and report writing.
Experience providing oversight to external vendors, such as CROs, central laboratories, call centers, or DCT providers.
Working knowledge of ICH Guidelines and GCP, including international regulatory requirements for clinical development programs.
Advanced computer skills, including Microsoft Word, Excel, Project, Access, and PowerPoint.
Experience managing projects in matrixed and virtual environments.
Fluent written and spoken English.
Excellent communication, planning, and organizational skills.
Ability to lead by example and encourage team members to find solutions independently.
Ability to manage competing priorities and use resources effectively.
Ability to inspire teamwork and motivate staff in a matrix system.
Financial awareness and ability to use financial tracking systems effectively.
Ability to work independently and mentor junior project team members.
Ability to negotiate and liaise professionally with clients.
Ability to present to staff at all levels.
Prior monitoring experience.

Nice To Haves

Life science degree preferred.

Responsibilities

Drive clinical project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence.
Promote communication and collaboration with clients and project teams in a matrixed, multicultural environment.
Lead development and prioritization of clinical project strategy, including proactive management of scope, timelines, quality, and budget.
Prepare and deliver presentations for new business in collaboration with relevant departments.
Manage project operations supporting subject recruitment and retention, clinical vendor delivery, and monitoring visit strategy.
Identify clinical, financial, and quality risks and apply end-to-end risk management and quality-by-design principles.
Use data sources, dashboards, and risk management strategies to support innovation and proactive problem-solving.
Follow project governance and escalation pathways, and ensure plans address risks while meeting professional, SOP, client, and regulatory requirements.
Oversee clinical project budgets, resources, scope, and financial milestones; forecast revenue and manage costs within budget.
Lead timely scope changes and the change order process.
Ensure project teams understand and track KPIs, including client-specific metrics.
Provide leadership to build high-performing clinical project teams and ensure team members understand contracted scope, timelines, and budget.
Ensure clinical resource projections are accurate and visible to resourcing teams, and escalate resource constraints proactively.
Develop and mentor team members and provide feedback to their line managers.
Participate in and oversee regulatory and ethics committee submissions, tracking, and documentation as required by project roles.
Support new business through participation in bid defense preparation and meetings as required.
Perform other duties as needed or assigned.