Clinical Team Lead – Ophthalmology

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Take charge of the clinical execution of clinical research trials as the Clinical Team Lead.

• Act as the Clinical Project Manager within the core project team.

• Collaborate with the Project Manager and functional leads to ensure clinical trial elements meet contractual and budgetary expectations.

• Supervise clinical and site management activities during trials.

• Represent clinical delivery to clients.

• Propel clinical project performance towards fulfilling contracted deliverables and addressing customer needs.

• Lead communication and collaboration efforts with clients and matrixed, multicultural project teams.

• Formulate clinical project strategies and prioritize data-driven approaches alongside stakeholders.

• Actively manage project scope, timelines, quality, and budget.

• Prepare and present proposals for new business opportunities.

• Oversee project operations that support subject recruitment and retention.

• Manage clinical vendor delivery and monitoring visit strategies.

• Identify and mitigate clinical, financial, and quality risks using risk management and quality-by-design methodologies.

• Leverage data sources, dashboards, and risk management techniques for proactive problem resolution.

• Maintain project governance, issue escalation protocols, clinical project plans, SOPs, client specifications, and regulatory mandates.

• Manage clinical project budgets, resources, scope, revenue forecasting, expenses, financial milestones, KPIs, and change orders.

• Provide leadership for high-performing clinical project teams.

• Facilitate effective communication, teamwork, and delivery while ensuring awareness of scope, timelines, and budget.

• Ensure precise clinical resource projections and escalate any resource-related constraints.

• Mentor team members and provide constructive feedback to line managers.

• Engage in and supervise regulatory and ethics committee submissions, tracking, and documentation.

• Participate in Bid Defense preparations and meetings as needed.

• Perform other assigned duties.

⛳️ Requirements

• A university/college degree in life sciences is preferred, or certification in a relevant allied health profession from an accredited institution.

• Fortrea may consider relevant and equivalent experience as a substitute for educational qualifications.

• A Bachelor's degree.

• 5+ years of experience in clinical research/monitoring or a combination of education and experience that is equivalent.

• 3+ years of experience leading project teams through study start-up, conduct, data management, analysis, closeout, and report writing.

• Prior monitoring experience is required.

• Experience overseeing external vendors, including CROs, central labs, call centers, and DCT providers.

• Proficient understanding of ICH Guidelines and GCP, along with international regulatory requirements.

• Advanced proficiency in computer applications, including Microsoft Word, Excel, Project, Access, and PowerPoint.

• Experience managing projects in matrix and virtual settings.

• Exceptional communication, planning, and organizational skills.

• Ability to lead by example and motivate team members to independently seek solutions.

• Capacity to manage multiple competing priorities and utilize resources efficiently.

• Ability to inspire teamwork and motivate staff within a matrixed environment.

• Financial acumen and proficiency in financial tracking systems.

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

• Capable of negotiating and maintaining professional relationships with clients.

• Competent in presenting to staff at all organizational levels.

• Fluent in English, both written and verbal.

• Willingness to travel up to 30% globally, primarily domestically and internationally.

• Availability for weekend and off-hour work as necessary.

🏝️ Benefits

• Option for remote-based work.

• Standard office environment or remote-based work availability.

• Fortrea's EEO and accommodations support.