At a Glance
- 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: This role requires EU work permit; ideal for those passionate about advancing healthcare.
The predicted salary is between 36000 - 60000 £ 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.
- 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: JR United Kingdom
Contact Detail:
JR United Kingdom 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. Attend industry conferences, webinars, or local meetups to connect with others who work in clinical trials. This can help you learn about job openings and get referrals.
✨Tip Number 2
Stay updated on the latest trends and regulations in clinical trials, especially those related to oncology. Follow relevant publications and join online forums to engage with current discussions, which can give you an edge during interviews.
✨Tip Number 3
Consider reaching out to current or former employees of Advanced Clinical. They can provide insights into the company culture and expectations for the Senior Clinical Trial Manager role, helping you tailor your approach.
✨Tip Number 4
Prepare for potential interview questions by practising your responses to common scenarios faced in clinical trial management. Focus on your experience with early-phase oncology studies and how you've successfully managed challenges in past roles.
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 align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for oncology and your understanding of the clinical trial process. Mention specific experiences that demonstrate your ability to oversee clinical trial sites and manage relationships with CROs and investigators.
Highlight Relevant Skills: In your application, clearly outline your skills related to project management, communication, and problem-solving. Provide examples of how you've successfully navigated challenges in previous clinical trials.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in clinical trial management.
How to prepare for a job interview at JR United Kingdom
✨Showcase Your Oncology Expertise
Make sure to highlight your experience with 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.
✨Understand Regulatory Requirements
Familiarise yourself with GCP, ICH guidelines, and relevant CFRs. During the interview, be ready to explain how you ensure compliance in your previous roles. This shows that you are detail-oriented and understand the importance of regulations in clinical trials.
✨Demonstrate Leadership Skills
As a Senior Clinical Trial Manager, you'll likely oversee other team members. Share examples of how you've successfully led teams or managed CROs in the past. Highlight your ability to motivate others and ensure project deliverables are met.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills. Prepare for scenarios where you might need to address protocol deviations or manage recruitment challenges. Think through your responses to show your proactive approach and ability to handle pressure.