Project Manager

🕒 Maio 30

🔔 Pennsylvania – Remoto

🔔 Pennsylvania – Remote

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

👷‍♀️ Gerente de Projetos

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ICON plc

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1990

💊 Farmacêutico

🧬 Biotecnologia

⚕️ Seguro de Saúde

Pharmaceuticals • Biotechnology • Healthcare Insurance

A ICON plc é uma provedora global de serviços clínicos, de consultoria e comerciais que atendem a diversos setores das indústrias de saúde e farmacêutica. A empresa oferece uma ampla gama de soluções clínicas, incluindo ensaios clínicos descentralizados, soluções de segurança cardíaca, laboratórios clínicos de fases iniciais e imagem médica. A ICON também fornece soluções de tecnologia que apoiam o desenvolvimento de medicamentos desde as fases iniciais até o pós-comercialização. Sua expertise terapêutica abrange cardiovascular, oncologia, medicina interna e mais, com forte foco em terapias transformadoras, como terapias celulares e gênicas e biossimilares. Reconhecida como uma das principais CROs (Contract Research Organisations), a ICON oferece regularmente thought leadership e contribui para publicações e eventos do setor. Seus serviços são personalizados para otimizar ensaios clínicos, fornecer inteligência regulatória e gerar evidências do mundo real por meio de análise de dados robusta e soluções centradas no paciente.

Descrição

• Develop and manage timelines and budgets for post-trial access (PTA) programs supporting investigational products prior to regulatory approval • Ensure compliance with regulatory requirements and company Policies/SOPs • Lead cross-functional teams and serve as primary program contact for PTA/Continued Access programs • Populate PTA templates and tools with program-specific information related to investigational product access decisions and implementation • Drive development and finalization of core program documents (e.g. PTA Treatment Guidelines, PTA ICF, agreements and contracts) • Drive decision-making, including selection of appropriate regulatory mechanisms, supply strategy, and safety reporting, in collaboration with cross-functional stakeholders; with support as needed • Ensure alignment across PTA program decisions, documentation, plans, and implementation • Provide forecasting and ensure investigational supply strategies are developed and executed, in collaboration with Supply Chain, to facilitate uninterrupted patient access to investigational products • Manage requests for investigational product access through PTA programs, ensuring timely and compliant processing • Manage vendor contracting and deliverables in support of PTA/continued access program execution • Utilize PTA tools, templates, and systems to ensure accurate tracking and reporting of investigational access programs • Monitor quality, KPIs, and program performance; identify issues and escalate as needed • Communicate PTA program status, risks, and updates to stakeholders • Identify risks and implement mitigation strategies specific to investigational product access and program continuity; capture lessons learned and best practices • Ensure inspection readiness, maintain complete and accurate documentation, and perform quality checks for PTA programs • Support other PTA/continued access activities and programs, as assigned

🎯 Requisitos

• BS/BA (or equivalent experience) • Experience in clinical research or biopharmaceutical operations; including 2+ years leading global, multi-regional PTA programs across the lifecycle, for investigational products prior to regulatory approval; comparable experience leading expanded access/compassionate use programs or significant experience contributing to PTA or EAP may be considered • General understanding of regulatory frameworks governing pre-approval and continued access to investigational products, ICH GCP, and ethical frameworks of clinical research • Demonstrated ability to manage mild to moderately complex, multi-region PTA programs involving investigational products with a degree of operational and regulatory complexity, with minimal supervision • Proven experience collaborating effectively; influencing stakeholders across functions and levels • Evidence of strong project management skills; including managing competing priorities and solving operational challenges in clinical or investigational program environments • Successful history of working independently in a global environment • Experience with automating processes, process mapping and/or certification in Lean or Six Sigma would be considered an advantage, though it is not a mandatory requirement.

🏖️ Benefícios

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways