Sr Clinical Trial Manager

JR United Kingdom; Newcastle upon Tyne; On-site; GBP 60,000 - 80,000; Full time

Job summary

A leading Oncology-focused midsized pharma company seeks a Senior Clinical Trial Manager to oversee early-phase studies across the UK and mainland Europe. This role requires a robust background in clinical operations with a specific focus on oncology, ensuring trial compliance and managing relationships with sites and investigators effectively.

Qualifications

• Minimum of 5 years of clinical operational experience in biotechnology, pharmaceuticals, and CROs.
• Strong understanding of GCP, ICH, GDP, and relevant CFRs.
• Experience with clinical trial site start-up and initiation.

Responsibilities

• Oversee clinical trial sites from start-up to close-out, ensuring compliance.
• Collaborate with Clinical Project Manager and vendors to manage studies.
• Develop and oversee patient recruitment and retention strategies.

Skills

Strong communication skills

Proactive in identifying project challenges

Ability to work independently

Knowledge and experience in oncology

Job description

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Sr Clinical Trial Manager, Newcastle-upon-Tyne, Tyne and Wear

Client: Advanced Clinical

Location: Newcastle-upon-Tyne, Tyne and Wear, United Kingdom

Job Category: Other

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EU work permit required: Yes

Job Views:

4

Posted:

06.06.2025

Expiry Date:

21.07.2025

Job Description:

Senior Clinical Trial Manager (via FSP)

Oncology-Focused Midsized Pharma Company - Early Phase

This role will focus on the Early Phase Oncology program in the UK and mainland Europe. 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, GCP, and regulatory requirements. They collaborate with the Clinical Project Manager (CPM), CRO representatives, and vendors to manage clinical studies effectively. They may supervise Clinical Trial Managers to ensure deliverables are met on time, within budget, and to quality standards.

• Participate in planning, implementing, and managing clinical trials in compliance with industry regulations and ICH-GCP. Oversee CROs and sites, ensuring timely delivery, recruitment targets, and 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 protocols and manage CRO/site during start-up activities, including contract negotiations and document collection.
• 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 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).