Clinical Team Lead, Phase I

Fortrea; United States; Remote; MXN 700,000 - 1,100,000; Full time

Job summary

Fortrea is seeking an experienced Clinical Trial Manager to join the Phase I team. This homebased role can be conducted from the US, Canada, or Mexico, offering flexibility to work remotely within a global clinical delivery setup.

As a Clinical Team Lead, you will oversee the clinical delivery of trials, partner with project managers and functional leads, and guide site management, risk assessment, and budget adherence to ensure high-quality trial execution.

Qualifications

• University/college degree (life science preferred) or related allied health certification; relevant experience may substitute education.
• Fluent in English, both written and verbal.
• Experience in clinical project delivery and management is preferred.

Responsibilities

• Take accountability for driving clinical project performance toward contracted deliverables with client satisfaction.
• Drive communication and collaboration with the client and project team in a matrixed, multicultural environment.
• Develop clinical project strategy and ensure prioritization with the team and stakeholders; create data-driven strategies and manage scope, timelines, quality and budget.
• Manage operational aspects to support recruitment, retention, vendor delivery, and monitoring visit strategy.
• Identify risks and apply end-to-end risk management and quality by design principles.
• Utilize data sources and dashboards to drive proactive problem solving.
• Ensure governance, escalation pathways, and adherence to SOPs, client, and regulatory requirements.
• Oversee budgets, resources and scope; forecast revenue and control costs.
• Lead and mentor team members; participate in regulatory submissions as needed.
• Support new business with Bid Defense participation.

Skills

English fluency

Communication

Planning

Organizational skills

Microsoft Word

Excel

PowerPoint

Access

Project

Education

University/college degree (life science preferred)

Related allied health certification (optional)

Tools

Microsoft Word

Excel

Project

Access

PowerPoint

Job description

We are currently seeking an experienced Clinical Trial Manager to join our Phase I team! Homebased within the US or Canada Or Mexico

What You Will Do

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Job Overview

Clinical Team Leads (CTL) own the clinical delivery of clinical research trials. CTLs function as the Clinical Project Manager (CPM) within the core project team. CTLs partner with the Project Manager and other functional leads to ensure successful delivery of the clinical aspects of a trial within contractual and budgetary requirements. The CTL oversees the clinical and site management aspects of the trial. The CTL represents clinical delivery with the given customer.

Responsibilities

• Take accountability for proactively driving clinical project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence.
• Drive communication and collaboration with the client and project team across a matrixed, multicultural, environment.
• Lead the development of the clinical project strategy and ensures prioritization with the clinical 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.
• Manage the operational aspects of projects to support subject recruitment and retention, clinical vendor delivery and oversee the monitoring visit strategy.
• Identify clinical project, financial and quality risks 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.
• Adhere to project governance and issue escalation pathways, ensuring that clinical 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 clinical project budgets, resources and scope.
• Ensure adherence to established budget and financial milestones. Accountable for accurately forecasting clinical 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 clinical project teams. Facilitating communication and teamwork while driving delivery, ensuring that clinical team members understand contracted scope, timelines and budget.
• Ensures that clinical 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 provide feedback as needed to respective line managers
• As required by the project roles participate and oversee the regulatory/ethics committee submissions, tracking, and documentation.
• Support new business with active participation in Bid Defense preparation and meetings, as required.
• And 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.
• Fluent in English, both written and verbal.

Experience (Minimum Required)

• 2+ years of Clinical Team Lead experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job.
• Phase I/FIH 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 and effectively 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 or other advanced degree
• PMP certification 2+ years CRA experience, on-site or in-house

Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.