Clinical Team Lead, Phase I

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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

• Utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. • Own the clinical delivery of clinical research trials as the Clinical Team Lead (CTL). • 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 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. • Ensure adherence to established budget and financial milestones; lead timely management of changes to scope and the change order process. • 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. • 2+ years of Clinical Team Lead 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.

🏖️ Benefits

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) • 401(K) • Paid time off (PTO) – Flex Plan • Employee recognition awards • Multiple ERG’s (employee resource groups)