Director, Clinical Trial Strategy – Optimization

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🕒 6 dias atrás

🎸 Tennessee – Remoto

🎸 Tennessee – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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McKesson

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1833

⚕️ Seguro de Saúde

💊 Farmacêutico

🧬 Biotecnologia

Healthcare Insurance • Pharmaceuticals • Biotechnology

A McKesson é uma líder diversificada em saúde, especializada em distribuição farmacêutica, suprimentos médicos e serviços de saúde. Suas soluções facilitam o acesso de pacientes a terapias transformadoras, apoiam operações eficientes para farmácias, sistemas de saúde e clínicas, e abordam questões críticas como a escassez de medicamentos por meio de uma cadeia de suprimentos resiliente. A McKesson oferece serviços abrangentes como software de gestão de farmácias, consultoria e soluções tecnológicas para práticas especializadas, focando em melhorar os resultados de saúde e promover a indústria farmacêutica. Eles trabalham em estreita colaboração com empresas biofarmacêuticas para melhorar o acesso a medicamentos, adesão e comercialização, enquanto apoiam práticas oncológicas e biofarmacêuticas por meio de insights orientados por dados e evidências do mundo real.

Descrição

• Identify opportunities to optimize clinical trial processes across the study lifecycle and drive process changes that improve speed, quality, consistency, and operational efficiency. • Lead cross-functional teams in the design, implementation, and sustainment of process improvements that support high-quality and timely clinical trial delivery. • Ensure site perspectives are represented in process redesign efforts and partner with site stakeholders to bring them along through change planning, communication, training, and adoption. • Assess current-state workflows, identify root causes of inefficiencies, and prioritize improvement initiatives based on business impact, feasibility, and alignment with strategic goals. • Develop and monitor key performance indicators, dashboards, and reporting to track process improvement outcomes, risks, and opportunities across clinical trial operations. • Report progress, insights, and recommendations to executive leadership, providing clear updates on strategic initiatives, implementation status, and measurable impact. • Establish governance, documentation, and standard work to support consistent execution of updated processes and promote a culture of continuous improvement. • Build strong partnerships across clinical, operational, quality, technology, and site teams to align stakeholders, remove barriers, and deliver changes to process. • Collaborate with sites, sponsors, contract research organizations, and vendors as needed to support process alignment, operational readiness, and successful implementation of change. • Ensure process improvements are implemented in alignment with quality standards, regulatory requirements, and organizational priorities while maintaining focus on sustainable execution.

🎯 Requisitos

• Bachelor's Degree required • 5+ years of experience in clinical trials is required • Change and program management experience required • Knowledge of scientific, medical, and regulatory terms • Knowledge of ICH Guidelines, GCP, and CFR Title 21 • Clinical research process knowledge with an understanding of medical terminology • Sophisticated problem-solving skills • Highly organized • Flexible and adaptable • Strong communication skills; persuasive, encouraging, motivating, and inspiring; the ability to listen and understand; the ability to communicate the complex in simple terms • Ability to establish relationships - develop strategic relationships within and outside of direct organization • Facilitation and communication skills - able to drive plans, decisions, and resolve issues through facilitation of groups or individuals • Process improvement skills and techniques • Change management skills and techniques • Excellent active listening skills • Experience working in a matrix environment and with virtual team members / stakeholders • Ability to thrive in team environments of considerable change • Ability to define vision and lead through change • Ability to partner with individuals at all levels of management and across organization boundaries • Ability to work across many teams to identify business opportunities and drive to consensus

🏖️ Benefícios

• Total Rewards package • Comprehensive benefits to support physical, mental, and financial well-being