Senior Clinical Data Manager – Data Standards

🕒 il y a 4 jours

🌐 Royaume-Uni, Afrique du Sud, +2 autres pays – Distant

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⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 10%

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🗣️🇺🇸🇬🇧 Anglais requis

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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

• Lead the development and operationalisation of clinical data standards processes and best practices • Drive initiatives related to data cleaning, data quality, edit checks, data listings, and standards library management • Partner closely with Clinical Trial Reporting (CTR), Clinical Trial Configuration (CTC), and Cross-Functional Data Review (CFDR) teams • Establish governance, workflows, and quality standards to support clinical trial delivery • Lead and mentor Associate Manager-level team members while fostering a culture of continuous improvement • Collaborate with cross-functional stakeholders to translate strategic objectives into operational execution • Identify risks, drive process improvements, and promote data quality across the clinical data lifecycle

🎯 Exigences

• Bachelor's degree in Life Sciences, Health Sciences, or a related discipline • Extensive Clinical Data Management experience within a CRO, biotechnology, or pharmaceutical environment • Strong experience in process development, project management, stakeholder engagement, and cross-functional collaboration • Proven ability to build and operationalise new processes and ways of working • Experience in data quality, standards development, data review, edit checks, data listings, or standards library management • Strong understanding of clinical trial processes, regulatory requirements, and ICH-GCP • Excellent communication, problem-solving, and leadership skills • An entrepreneurial mindset with the ability to thrive in a developing and evolving function • 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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