Senior Manager, Clinical Operations

🔥 il y a 20 heures

🇬🇧 Royaume-Uni – Télétravail

💵 $147 300 - $220 900 / an

⏰ Temps Plein

🟠 Senior

🏥 Responsable des Opérations Cliniques

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Precision For Medicine

Site WebLinkedInTous les Emplois

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

💰 €75 000 000 Private Equity Round en 2015-12

Healthcare • Consulting • Logistics

Precision for Medicine est un leader spécialisé dans l’accompagnement du développement et de la mise sur le marché de thérapies innovantes, notamment en oncologie, dans les maladies rares et les maladies auto-immunes. Grâce à une gamme complète de services — gestion d’essais cliniques, services de laboratoire et collecte de biospécimens — l’entreprise intègre des capacités avancées en biomarqueurs ainsi que des solutions de fabrication pour fluidifier des processus de développement clinique complexes. Sa mission est d’accélérer la recherche et d’apporter aux patients des solutions médicales qui changent la vie, en dépassant les inefficacités traditionnelles souvent observées dans le paysage du développement pharmaceutique.

Description

• Serve as the Clinical Process Owner for Clinical Operations processes, ensuring governance, accountability, lifecycle management, and alignment across regions and functions • Lead development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs, work instructions, tools, templates, and related documentation • Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity • Translate regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback into process solutions • Lead and represent cross-functional process governance and decision-making across Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other functions • Lead process implementation and change management, including impact assessment, stakeholder engagement, training, communication, adoption monitoring, and effectiveness evaluation • Act as a senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvements, and business development support • Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings; represent process capabilities, delivery models, and operational strengths to prospective clients • Lead cross-functional working groups, process teams, and strategic improvement initiatives as needed

🎯 Exigences

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered • 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment • Proven experience leading complex cross-functional or global process improvement initiatives from assessment and design through implementation and effectiveness evaluation • Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes • Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles • Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization • Preferred: experience owning or leading Clinical Operations SOPs, work instructions, and controlled documentation • Preferred: experience with process mapping, change management, Lean, or continuous improvement methodologies • Preferred: expert understanding of Clinical Operations processes and cross-functional interfaces • Preferred: ability to interpret regulatory and quality requirements and translate them into practical processes