FSP - Clinical Team Lead - Ophthalmology - US

NCBioImpact; Durham (NC); Remote; USD 135,000 - 147,000; Full time

Benefits offered by this job

Remote work option

Travel up to 30%

Job summary

Fortrea is seeking an Ophthalmology Clinical Team Lead (CTL) to join our FSP team on a remote US basis. The CTL will own clinical delivery, manage budgets, and partner with cross-functional teams to ensure trial success.

The role requires 2+ years of CTL or equivalent experience in clinical research/monitoring, strong leadership, and a proven ability to drive risk-based strategies in a matrix, virtual environment. Travel up to 30% may be required.

Qualifications

• Bachelor's degree or equivalent in life sciences or related field.
• 5+ years clinical research/monitoring experience or equivalent.
• Experience leading project teams in a matrix/virtual environment.
• Strong command of GCP/ICH guidelines and regulatory requirements.
• Advanced computer skills with MS Office Suite.

Responsibilities

• Drive clinical project performance to meet contracted deliverables.
• Lead development and prioritization of clinical project strategy.
• Manage subject recruitment, vendor oversight, and monitoring visits.
• Forecast revenue and control project costs within budget.
• Mentor team members and oversee resource planning.
• Communicate with clients and internal stakeholders to manage scope and timelines.

Skills

Leadership

Communication skills

Project management

Risk management

Budgeting

Education

Bachelor's degree

Life science degree preferred

Certification in allied health field

Tools

Microsoft Word

Excel

PowerPoint

Microsoft Project

Access

Job description

Fortrea is seeking Ophthalmology Clinical Team Leads to join our FSP team! We are seeking experienced CTLs with 2+ years of experience. Prior monitoring experience required. Remote US.

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.

Summary of 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):

• Bachelor's degree
• 5+ years clinical research/monitoring experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job.
• 3+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies.
• Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers).
• 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.

Pay Range: $135,000-147,000 USD annually

Physical Demands/Work Environment:

• Standard Office Environment or remote based work required
• Weekend and off-hour work as required
• Travel Requirements: up to 30% (Global – primary domestic and international)

Learn more about our EEO & Accommodations request here.