Sr Clinical Trial Manager

JR United Kingdom; Cheltenham; On-site; GBP 60,000 - 80,000; Full time

Job summary

Une entreprise pharmaceutique spécialisée en oncologie recherche un Senior Clinical Trial Manager pour superviser les études cliniques de la phase précoce au Royaume-Uni et en Europe. Le candidat idéal aura au moins cinq ans d'expérience en gestion d'essais cliniques, une solide compréhension des GCP et des capacités de communication exceptionnelles. Ce rôle est crucial pour garantir la conformité et la qualité des études tout en supervisant les équipes et en collaborant avec divers partenaires.

Qualifications

• Minimum de 5 ans d'expérience en opérations cliniques dans les biotechnologies ou les produits pharmaceutiques.
• Compréhension des GCP, ICH, CFD, et des régulations internationales est un plus.
• Expérience en démarrage et initiation de sites d'essai clinique.

Responsibilities

• Surveiller les sites d'essai clinique de la phase de démarrage jusqu'à la clôture.
• Collaborer avec le CPM, les représentants du CRO et les fournisseurs pour gérer efficacement les études cliniques.
• Développer des stratégies de recrutement et de rétention des patients.

Skills

Gestion des essais cliniques

Conformité aux GCP et ICH

Communication

Relations avec les sites d'essai

Proactif

Connaissance en oncologie

Job description

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Oncology-Focused Midsized Pharma Company - Early Phase

This role will focus on the Early Phase Oncology program in the UK and mainland Europe. To be considered for this position, candidates must have recent experience with early-phase oncology studies at a CRO, biotech, or pharmaceutical company.

Summary

The Senior Clinical Trial Manager oversees clinical trial sites from start-up to close-out, ensuring compliance with the study protocol, ICH guidelines, Good Clinical Practices (GCP), and regulatory requirements. They collaborate with the Clinical Project Manager (CPM), CRO representatives, and vendors to manage clinical studies effectively. Additionally, they may supervise Clinical Trial Managers to ensure deliverables are met on time, within budget, and to quality standards.

• Participate in the planning, implementing, and managing of clinical trials in compliance with industry regulations and ICH-GCP. - Oversee CROs and clinical trial sites, ensuring timely delivery, meeting recruitment targets, and producing high-quality data.
• Track site visit metrics, data quality concerns, and protocol deviations; conduct oversight visits for compliance evaluation. - Assist in initiation visits to confirm site training and foster relationships among sponsors, CROs, and investigators.
• Review CRA monitoring reports to ensure protocol and operational compliance; escalate issues for resolution.
• Collaborate with teams for efficient study start-up, identifying risks and ensuring timelines are met.
• Act as a subject matter expert on assigned protocols and manage CRO/site during start-up activities, including contract negotiations and document collection.
• Could you provide direction to ensure consistency in Clinical Operations processes across trials and regions?
• Work cross-functionally with departments to meet study requirements and timelines.
• Contribute to developing and reviewing study-related documents and deliver trial-specific training.
• Monitor open action items and data trends, addressing issues with CROs to enhance study execution and efficiency.
• Develop and oversee patient recruitment and retention strategies, acting on any deviations from the plan.

Experience

• Minimum of 5 years of clinical operational experience in biotechnology, pharmaceuticals, and CROs.
• Strong understanding of GCP, ICH, GDP, and relevant CFRs; familiarity with MHRA, EMA, and international regulations is a plus.
• Experience with clinical trial site start-up and initiation.
• Proven ability to build and maintain relationships with clinical trial sites and Principal Investigators.
• Strong communication skills for coordinating activities with internal teams, sites, and vendors.
• Proactive in identifying project challenges and proposing corrective actions with minimal supervision.
• Capable of working independently and delivering high-level presentations.
• Knowledge and experience in oncology.
• Previous experience as a Clinical Research Associate (CRA).