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Sr Clinical Trial Manager, Stoke-on-Trent
Client: Advanced Clinical
Location: Stoke-on-Trent, 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.
Responsibilities:
- Oversee clinical trial sites from start-up to close-out, ensuring compliance with protocols, ICH guidelines, GCP, and regulations.
- Collaborate with Clinical Project Manager, CROs, and vendors to manage studies effectively.
- Supervise Clinical Trial Managers to meet deliverables on time, within budget, and to quality standards.
- Participate in planning, implementing, and managing clinical trials in compliance with regulations.
- Oversee CROs and sites, ensuring timely delivery and high-quality data.
- Monitor site visit metrics, data quality, and protocol deviations; conduct oversight visits.
- Assist in site initiation visits and foster relationships among sponsors, CROs, and investigators.
- Review monitoring reports and escalate issues as needed.
- Coordinate study start-up activities, 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 train staff.
- Monitor action items and data trends, addressing issues with CROs.
- Develop patient recruitment and retention strategies.
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 site start-up and initiation.
- Ability to build relationships with trial sites and investigators.
- Strong communication skills.
- Proactive problem-solving skills.
- Ability to work independently and present effectively.
- Knowledge and experience in oncology.
- Previous CRA experience preferred.