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- Tasks: Lead early-phase oncology clinical trials from start to finish, ensuring compliance and quality.
- Company: Join a dynamic midsized pharma company focused on innovative oncology solutions.
- Benefits: Enjoy competitive pay, flexible working options, and opportunities for professional growth.
- Why this job: Make a real impact in cancer research while collaborating with top professionals in the field.
- Qualifications: 5+ years in clinical operations, strong GCP knowledge, and oncology experience required.
- Other info: Opportunity to work across UK and Europe, enhancing your global experience.
The predicted salary is between 48000 - 72000 £ per year.
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.
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.
- 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).
Sr Clinical Trial Manager employer: Advanced Clinical
Contact Detail:
Advanced Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr Clinical Trial Manager
✨Tip Number 1
Network with professionals in the oncology field, especially those who have experience in early-phase clinical trials. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in oncology research.
✨Tip Number 2
Familiarise yourself with the specific regulations and guidelines related to clinical trials in the UK and mainland Europe. Understanding the nuances of MHRA and EMA regulations can set you apart from other candidates and demonstrate your commitment to compliance.
✨Tip Number 3
Showcase your ability to manage relationships with clinical trial sites and Principal Investigators. Prepare examples of how you've successfully built these relationships in past roles, as this is crucial for the Senior Clinical Trial Manager position.
✨Tip Number 4
Highlight your proactive problem-solving skills during interviews. Be ready to discuss specific challenges you've faced in previous clinical trials and the corrective actions you implemented to overcome them, as this will demonstrate your capability to handle the responsibilities of the role.
We think you need these skills to ace Sr Clinical Trial Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in early-phase oncology studies. Emphasise your roles in managing clinical trials, compliance with GCP and ICH guidelines, and any specific achievements that demonstrate your expertise.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this position. Discuss your understanding of the role and how your background aligns with the company's focus on early-phase oncology. Be sure to mention any specific experiences that relate directly to the job description.
Highlight Key Skills: In your application, make sure to highlight key skills such as project management, communication, and relationship-building with clinical trial sites. Use specific examples to illustrate how you've successfully applied these skills in previous roles.
Proofread Your Application: Before submitting your application, take the time to proofread all documents. Check for spelling and grammatical errors, and ensure that your information is clear and concise. A polished application reflects your attention to detail, which is crucial in clinical trial management.
How to prepare for a job interview at Advanced Clinical
✨Showcase Your Oncology Expertise
Make sure to highlight your specific experience in early-phase oncology studies. Discuss any relevant projects you've managed and the outcomes achieved, as this will demonstrate your suitability for the role.
✨Demonstrate Compliance Knowledge
Be prepared to discuss your understanding of GCP, ICH guidelines, and regulatory requirements. Providing examples of how you've ensured compliance in past trials can set you apart from other candidates.
✨Highlight Relationship-Building Skills
Since the role involves collaboration with various stakeholders, share examples of how you've successfully built and maintained relationships with clinical trial sites and Principal Investigators. This will show your ability to foster teamwork.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think of challenges you've faced in previous roles and how you addressed them, particularly in relation to site management and study execution.
