Director, Project Management – Rare Disease & Pediatrics

🔥 7 horas atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $160.000 - $180.000 / ano

⏰ Tempo Integral

🔴 Especialista

👷‍♀️ Gerente de Projetos

👻 Score fantasma 0%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Fortrea

10.000+ funcionários

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

Healthcare • Biotechnology • Pharmaceuticals

Fortrea é uma organização de pesquisa clínica (CRO) com mais de 30 anos de experiência, dedicada a acelerar o desenvolvimento de tratamentos que mudam vidas ao fornecer soluções clínicas abrangentes para empresas biofarmacêuticas e de MedTech. A empresa oferece uma gama de serviços, incluindo gestão de ensaios clínicos, serviços de farmacologia e estratégia regulatória, todos concebidos de acordo com as necessidades dos clientes. A missão da Fortrea é colocar os pacientes no centro do seu trabalho, buscando levar terapias inovadoras ao mercado mais rapidamente por meio de abordagens personalizadas e orientadas por dados.

Descrição

• Act as the primary client lead for complex clinical studies or programs • Drive operational delivery across multiple vendors, sub-CROs, and teams • Develop and execute risk-management strategies • Resolve escalated project-level issues • Provide line management and talent development for project management staff • Lead project teams through the design, implementation, tracking, and maintenance of project plans • Adhere to professional standards, SOPs, contracted timelines, and budgets • Oversee TMF Index and Plan, audit readiness, and TMF delivery when contracted by the client • Lead quality control and risk assurance activities • Foster positive client experiences through communication and collaboration • Develop and manage strategic relationship documents, including charters, MSA negotiation, rate card input, operations plans, and quality plans • Initiate process improvement to address variance • Design delivery strategies for large-scale bid defense and perform business development activities • Attract, select, onboard, develop, and retain high-performing talent • Strengthen talent bench and succession • Perform other duties as assigned

🎯 Requisitos

• Fluent in English, both written and verbal • Extensive knowledge of the clinical development spectrum and ICH GCP • Advanced proficiency in organizational and time management skills • Sound judgment in high-stakes or ambiguous situations • Exceptional presentation skills for internal and partner executive leadership • Active contribution to continuous improvement and strategic planning • University/college degree in life sciences • Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO • At least six (6) years of full project management responsibility • Minimum of four (4) years direct or indirect supervisory experience • In lieu of the above experience requirement, a combination of other relevant and equivalent experience may be considered • Preferred therapeutic areas: rare diseases, neonatal and infant pediatric studies • PMP or certification in clinical research preferred

🏖️ Benefícios

• Medical • Dental • Vision • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(k) • Paid time off (PTO) or flexible time off (FTO) • Company bonus where applicable

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