Clinical Trial Manager

Fortrea; São Paulo; Hybrid; BRL 180,000 - 300,000; Full time

Job summary

Fortrea Brazil seeks a Clinical Team Lead to own the clinical delivery of trials, partnering with the Project Manager and function leads to ensure successful delivery within budget and timelines. The CTL oversees clinical and site management and represents clinical delivery to the customer.

The role requires 2+ years of clinical research experience, English fluency, and strong leadership with budgeting and strategic planning capabilities in a matrix environment.

Qualifications

• University/college degree (life science preferred) or related allied health profession
• Fluent in English, both written and verbal.
• 2+ years clinical research/monitoring experience or equivalent
• Knowledge of ICH Guidelines and GCP and international regulatory requirements
• Advanced computer skills: Word, Excel, Project, Access, PowerPoint

Responsibilities

• Take accountability for driving clinical project performance toward contracted deliverables.
• Lead collaboration with client and project team in a matrix and multicultural environment.
• Develop clinical project strategy and manage scope, timelines, quality and budget.
• Prepare and deliver presentations for new business in collaboration with relevant departments.
• Manage operational aspects to support recruitment, vendor delivery, and monitoring visits.

Skills

Excellent communication

Leadership

Project management

Team motivation

Education

University/college degree (life science preferred) or related allied health certification

Tools

Microsoft Word

Microsoft Excel

Microsoft Project

Microsoft Access

PowerPoint

Job description

Job Overview

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)

• 2+ years clinical research/monitoring experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job.
• 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

• Master or other advanced degree
• PMP certification
• 2+ years CRA experience, on-site or in-house
• In lieu of the above minimum requirement, candidates with three or more years of relevance clinical research experience in pharmaceutical, CRO or health care setting will be considered

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)

EEO & Accommodations

EEO & Accommodations request.

At Fortrea, we're all about turning the “impossible” into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.