Clinical Process Change Manager

Emploi pas sur LinkedIn

🕒 il y a 24 jours

⏰ Temps Plein

🟠 Senior

🔴 Expert

👔 Manager

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

Publiée sur la page carrières de ICON plc, pas via un site d'emploi

Repérée par Remote Rocketship il y a 24 jours

Toujours ouverte sur le site de ICON plc. Vérifiée il y a 4 heures.

Logo of ICON plc

ICON plc

10 000+ employés

Fondée en 1990

💼 Conseil

🏥 Santé

📦 Logistique

Consulting • Healthcare • Logistics

ICON plc est un fournisseur mondial de services cliniques, de conseil et commerciaux à travers divers secteurs des industries de la santé et pharmaceutique. Ils offrent une vaste gamme de solutions cliniques, incluant des essais cliniques décentralisés, des solutions de sécurité cardiaque, des laboratoires cliniques précoces et de l'imagerie médicale. ICON fournit également des solutions technologiques qui soutiennent le développement de médicaments depuis les premières phases jusqu'à la post-commercialisation. Leur expertise thérapeutique couvre les domaines cardiovasculaire, oncologie, médecine interne et plus encore, avec un fort accent sur les thérapies transformatrices telles que les thérapies cellulaires et géniques ainsi que les biosimilaires. ICON est reconnu comme un leader dans le domaine de l'Organisation de Recherche Clinique (CRO), apportant régulièrement un leadership éclairé et contribuant à des publications et événements de l'industrie. Leurs services sont conçus pour optimiser les essais cliniques, offrir de l'intelligence réglementaire et fournir des preuves du monde réel à travers une analyse de données robuste et des solutions centrées sur le patient.

Description

• Drive and manage all aspects of controlled document development, revision, and retirement • Ensure compliant, consistent, scalable, and efficient procedures and business processes • Provide process expertise and align cross-functionally with relevant stakeholders • Manage cross-functional special initiatives and projects related to business processes and GCO department operations • Drive projects proactively from initiation through implementation • Establish clear timelines, roles, responsibilities, and decision points • Anticipate risks and obstacles before they impact delivery • Manage numerous document revisions at different stages of development • Obtain timely input, reviews, endorsements, and approvals from multiple stakeholders • Translate complex operational concepts into concise, clear procedural language • Facilitate meetings and keep discussions focused on decisions and outcomes • Navigate disagreement and drive consensus among stakeholders • Communicate with senior leaders, functional SMEs, quality representatives, and operational teams • Identify inconsistencies, gaps, ambiguities, and procedural risks • Ensure documents align with corporate standards • Maintain rigor around version control, document formatting, references, workflows, and approval requirements

🎯 Exigences

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • 7-10+ years of Sponsor or CRO clinical research experience, ideally within late phase Clinical Operations, Clinical Project Management, Quality Assurance, Process Excellence, or a related function • Deep understanding of Good Clinical Practice (GCP) and the operational realities of global clinical trial execution • Demonstrated experience managing complex cross-functional initiatives that require coordination, influence, and accountability without direct authority • Strong familiarity with procedural governance, controlled document management, CAPAs, quality systems, and change management principles • Experience authoring, revising, reviewing, or governing procedural documents such as SOPs, Work Instructions, Templates, Forms, Job Aids, and Guidance Documents • Experience leading cross-functional projects of high complexity with cross-functional team members within and outside the department • Legal right to work in the country where the role is based

🏖️ Avantages

• 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

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