FSP - Clinical Team Lead - Ophthalmology

Accountabilities

• • Take ownership of clinical project delivery, ensuring contracted deliverables are achieved while meeting client expectations, quality standards, timelines, and operational requirements.
  • Develop and execute clinical project strategies in collaboration with project teams and stakeholders, prioritizing scope, timelines, quality, budget, and study objectives.
  • Lead communication and collaboration with clients, project managers, functional leads, vendors, and clinical teams in a matrixed, multicultural environment.
  • Oversee clinical and site management activities, including subject recruitment and retention, monitoring strategies, clinical vendor delivery, and study execution.
  • Identify, assess, and proactively manage clinical, financial, operational, and quality risks using end-to-end risk management and quality-by-design principles.
  • Leverage data sources, dashboards, KPIs, and risk-management tools to support proactive decision-making, innovation, and continuous improvement.
  • Ensure clinical project plans, governance processes, escalation pathways, SOPs, regulatory requirements, and professional standards are consistently followed.
  • Partner with stakeholders to manage project budgets, resources, scope, financial milestones, forecasts, and costs, ensuring effective financial control.
  • Lead scope changes and change-order processes while maintaining visibility of project metrics and client-specific requirements.
  • Build high-performing clinical project teams by providing leadership, facilitating collaboration, clarifying expectations, and maintaining accountability for delivery.
  • Monitor clinical resource requirements, maintain accurate projections, and proactively escalate capacity or resourcing challenges.
  • Develop and mentor team members, providing guidance, feedback, and opportunities to strengthen clinical and project-management expertise.
  • Oversee or participate in regulatory and ethics committee submissions, tracking, and documentation as required by the study.
  • Support business development activities, including preparation for and participation in bid defense meetings when needed.

  Requirements

  • Bachelor's degree in life sciences or a related discipline; certification in an allied health profession such as nursing, medical technology, or laboratory technology is also relevant. Equivalent experience may be considered in place of formal education.
  • 5+ years of clinical research and/or clinical monitoring experience, or an equivalent combination of education and experience.
  • At least 3 years of experience leading clinical project teams through study start-up, conduct, data management, analysis, close-out, and report writing.
  • Prior clinical monitoring experience is required.
  • Experience overseeing external vendors such as CROs, central laboratories, call centers, or decentralized clinical trial providers.
  • Strong working knowledge of ICH Guidelines, Good Clinical Practice (GCP), and international regulatory requirements governing clinical development programs.
  • Experience managing projects in matrixed and virtual environments, with the ability to coordinate effectively across functions and geographies.
  • Advanced proficiency with Microsoft Office applications, including Word, Excel, Project, Access, and PowerPoint.
  • Excellent communication, planning, organizational, and presentation skills, with the ability to engage stakeholders at all levels.
  • Demonstrated ability to lead by example, motivate team members, encourage independent problem-solving, and foster effective teamwork.
  • Strong ability to manage competing priorities, allocate resources effectively, and work independently.
  • Financial awareness and experience using financial tracking systems to monitor project performance and budgets.
  • Strong client-facing and negotiation skills, with the ability to communicate professionally and build productive relationships.
  • Fluency in English, both written and verbal.

  Benefits

  • Competitive annual salary range of $135,000–$145,000 USD.
  • Fully remote work opportunity for candidates based in United States.
  • Full-time position within a specialized clinical research environment.
  • Opportunity to lead international clinical studies and collaborate with multidisciplinary teams and external partners.
  • Exposure to global clinical research, regulatory, and operational practices.
  • Opportunities to mentor team members and contribute to high-performing clinical project teams.
  • Professional environment focused on quality, collaboration, innovation, and advancing clinical development.
  • Travel of up to 30%, including primarily domestic and international travel.
  • Standard remote/office working environment, with occasional weekend or out-of-hours work as required.