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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 Europe and develop your leadership skills in a supportive environment.
The predicted salary is between 48000 - 72000 £ per year.
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. 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).
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 in oncology research.
✨Tip Number 2
Familiarise yourself with the specific regulations and guidelines related to early-phase oncology studies, such as ICH-GCP and local regulatory requirements. This knowledge will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences managing clinical trial sites, particularly focusing on how you ensured compliance and met recruitment targets. Use specific examples to illustrate your problem-solving skills and ability to work under pressure.
✨Tip Number 4
Showcase your communication skills by being clear and concise when discussing your past collaborations with CROs and clinical trial sites. Highlight any successful strategies you implemented for patient recruitment and retention, as this is crucial for 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 role. Discuss your understanding of the oncology field and how your background aligns with the responsibilities of a Senior Clinical Trial Manager.
Highlight Key Skills: In your application, focus on key skills such as project management, communication, and relationship-building with clinical trial sites. Provide examples of how you've successfully navigated challenges in previous roles.
Showcase Relevant Experience: Detail your experience with CROs and clinical trial site start-up processes. Mention any specific projects where you contributed to patient recruitment strategies or compliance evaluations, as these are crucial for this position.
How to prepare for a job interview at Advanced Clinical
✨Showcase Your Oncology Expertise
Make sure to highlight your experience in early-phase oncology studies. Be prepared to discuss specific projects you've worked on, the challenges you faced, and how you overcame them. This will demonstrate your knowledge and passion for the field.
✨Emphasise Compliance Knowledge
Since the role requires a strong understanding of GCP, ICH guidelines, and regulatory requirements, be ready to discuss how you've ensured compliance in past trials. Share examples of how you've handled protocol deviations or data quality concerns.
✨Demonstrate Leadership Skills
As a Senior Clinical Trial Manager, you'll likely oversee other Clinical Trial Managers. Prepare to talk about your leadership style, how you motivate teams, and any experiences where you've successfully managed cross-functional collaborations.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities. Think of scenarios where you've had to identify risks or propose corrective actions during a trial. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
