Sr Clinical Trial Manager

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

Job summary

A prominent oncology-focused midsized pharma company is seeking a Senior Clinical Trial Manager to oversee clinical trial sites across the UK and mainland Europe. This pivotal role entails ensuring compliance with protocols, managing study timelines, and coordinating with internal teams and clinical sites. Candidates must possess significant experience and strong communication skills to drive clinical success and meet objectives.

Qualifications

• Minimum 5 years clinical operational experience.
• Strong understanding of GCP, ICH, and regulatory standards.
• Knowledge and experience in oncology.

Responsibilities

• Oversee clinical trial sites from start-up to close-out.
• Ensure compliance with study protocols and regulatory standards.
• Collaborate with CROs and site managers for timely delivery.

Skills

Communication

Relationship Building

Proactivity

Job description

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Client:

Advanced Clinical

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Job Category:

Other

EU work permit required:

Yes

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Job Views:

4

Posted:

06.06.2025

Expiry Date:

21.07.2025

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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 study protocols, ICH guidelines, GCP, and regulatory standards. 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 timely, within-budget, and high-quality deliverables.

• 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 quality data.
• Monitor site visit metrics, data quality, and protocol deviations; conduct oversight visits for compliance.
• Assist in initiation visits, site training, and relationship building among sponsors, CROs, and investigators.
• Review CRA monitoring reports for protocol and operational compliance; escalate issues as needed.
• Collaborate for efficient study start-up, risk identification, and timeline management.
• Manage CRO/site activities during start-up, including contract negotiations and documentation.
• Ensure consistency in Clinical Operations processes across trials and regions.
• Work cross-functionally to meet study requirements and timelines.
• Develop and review study documents and deliver trial-specific training.
• Monitor open action items and data trends; address issues with CROs to improve execution.
• Develop and oversee patient recruitment and retention strategies, addressing deviations.

Experience

• Minimum 5 years of clinical operational experience in biotech, pharma, or CROs.
• Strong understanding of GCP, ICH, GDP, CFRs; familiarity with MHRA, EMA, and international regulations is a plus.
• Experience with clinical trial site start-up and initiation.
• Ability to build and maintain relationships with trial sites and Principal Investigators.
• Strong communication skills for coordination with internal teams, sites, and vendors.
• Proactive in identifying challenges and proposing solutions with minimal supervision.
• Ability to work independently and deliver high-level presentations.
• Knowledge and experience in oncology.
• Previous experience as a CRA.