Clinical Team Lead, Phase I

This is a fully remote position, open to applicants in Mexico, +2 more countries.

📋 Description

• Deliver exceptional care to participants involved in clinical trials and manage emergency situations according to clinical research standards.

• Take ownership of the clinical execution of research trials and serve as the Clinical Project Manager within the core project team.

• Collaborate with the Project Manager and functional leads to ensure the successful execution of clinical trial activities within contractual and budgetary constraints.

• Supervise the clinical and site management aspects of trials, acting as the representative for clinical delivery with clients.

• Propel clinical project performance towards achieving contracted deliverables while addressing customer requirements and upholding operational excellence.

• Foster communication and cooperation with clients and project teams in a matrixed, multicultural setting.

• Lead the development and prioritization of clinical project strategy, including managing project scope, timelines, quality, and budget.

• Prepare and present information for new business opportunities as needed.

• Manage project operations that support subject recruitment and retention, clinical vendor delivery, and monitoring visit strategy.

• Identify risks related to clinical projects, finances, and quality, employing end-to-end risk management and quality-by-design principles.

• Leverage data sources, dashboards, and risk management strategies to promote innovation and proactive problem solving.

• Maintain project governance and issue escalation pathways, including clinical project plans that address identified risks.

• Oversee clinical project budgets, resources, and scope; ensure adherence to budget and financial milestones.

• Forecast clinical project revenue and manage project expenses within budgetary limits.

• Lead scope changes and the change order process; monitor KPIs for client-specific metrics.

• Provide leadership for high-performing clinical project teams and facilitate effective communication, teamwork, and delivery.

• Ensure accurate projections of clinical resources and escalate any resource constraints.

• Develop and mentor team members, offering feedback to line managers.

• Participate in and supervise submissions to regulatory and ethics committees, including tracking and documentation.

• Assist in new business initiatives through preparation for Bid Defense and participation in meetings.

• Perform additional duties as needed or assigned.

⛳️ Requirements

• A university or college degree (preferably in life sciences) or certification in a related allied health profession (such as nursing, medical, or laboratory technology) from an accredited institution.

• Relevant and equivalent experience may be considered in place of educational requirements by Fortrea.

• Proficient in English, both written and verbal.

• A minimum of 2 years of Clinical Team Lead experience or an equivalent combination of education and experience that enables the successful execution of key job responsibilities.

• Experience in Phase I/FIH studies.

• Strong understanding of ICH Guidelines and GCP, including international regulatory requirements for clinical development programs.

• Advanced skills in computer applications (e.g., Microsoft Word, Excel, Project, Access, and PowerPoint).

• Experience managing projects in a matrixed and virtual environment.

• Exceptional communication, planning, and organizational skills.

• Proven ability to lead by example and encourage team members to independently seek solutions.

• Ability to handle multiple competing priorities effectively and utilize resources efficiently.

• Proven capability to inspire effective teamwork and motivate staff within a matrix system.

• Financial awareness with the ability to effectively utilize financial tracking systems.

• Capacity to work independently and mentor junior project team members.

• Proficient in negotiating and liaising with clients in a professional manner.

• Ability to present information to staff at all levels.

• Preferred: Master's degree or other advanced qualifications.

• Preferred: PMP certification.

• Preferred: Over 2 years of CRA experience, either on-site or in-house.

🏝️ Benefits

• Commitment to Equal Employment Opportunity and support for accommodations.

• Flexible remote/home-based work arrangements.