Clinical Team Lead, FSP – Oncology

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• 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 ensure prioritization with the clinical project team and key stakeholders. • Manage the operational aspects of projects to support subject recruitment and retention, clinical vendor delivery, and oversee monitoring visit strategy. • Identify clinical project, financial and quality risks leveraging end to end risk management practices and quality by design principles. • 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. • Provide inspiring leadership and play a key role in the creation of high-performing clinical project teams.

🎯 Requirements

• 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 • Fluent in English, both written and verbal. • 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 leading project teams through clinical studies. • Oncology experience as a CTL • 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 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. • Ability to work independently and mentor junior project team members. • Ability to negotiate and liaise with clients in a professional manner.

🏖️ Benefits

• 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)