RTSM/eCOA Manager

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🕒 Junho 8

🔔 Pennsylvania – Remoto

🔔 Pennsylvania – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

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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

• Manage day-to-day scientific operations activities, supporting your team to deliver quality outcomes • Support design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems to meet protocol and study requirements • Partner with Clinical Operations and study teams to understand RTSM/IRT/eCOA requirements and ensure alignment on scope, timelines, and deliverables • Develop and manage User Requirement Specifications (URS) and system design documentation • Ensure completion, review, and filing of validation and testing documentation in accordance with quality standards • Provide ongoing RTSM/IRT subject matter expertise to cross‑functional study teams throughout the study lifecycle • Identify, investigate, and resolve system defects and issues in collaboration with Quality, Clinical Operations, and vendors on deviations • Manage change control and emergency system changes • Serve as the primary operational interface between study teams, RTSM vendors, and internal functional teams • Ensure RTSM systems and documentation comply with SOPs and applicable regulations • Oversee quality reviews, validation documentation approval • Managing RTSM user access requests, modifications, and removals, including oversight of periodic access reviews and audit readiness • Alignment with SOPs, regulatory expectations, and system security controls • Support the development and implement standardized RTSM processes • Document end‑to‑end RTSM workflows and associated guidance • Identify process gaps and drive continuous improvement aligned with SOPs and regulations • Ensure RTSM processes support inspection readiness and consistent execution • Develop role‑based RTSM training curricula and materials • Ensure training aligns with processes, system functionality, and regulatory expectations

🎯 Requisitos

• Bachelor’s degree required (BA/BS) • Minimum 5 years of operational experience in clinical trials within a pharmaceutical company and/or CRO • Strong knowledge of the clinical trial process, with deep expertise in RTSM/IRT (IVRS/IWRS) eCOA systems • End‑to‑end experience managing RTSM system builds and updates • Proven experience leading User Acceptance Testing (UAT) and validation activities • Hands‑on experience working with RTSM/IRT/eCOA vendors; vendor management experience required • Project management experience managing complex, matrixed studies or programs • Familiarity with testing and issue‑tracking tools • Ability to independently identify issues, analyze root causes, and implement solutions in a complex environment • Strong communication, negotiation, and stakeholder‑management skills • Demonstrated leadership, organization, and prioritization capabilities

🏖️ 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