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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 flexible working options, competitive salary, 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 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 clinical trial management, compliance with GCP and ICH guidelines, and any specific achievements that demonstrate your capability in this area.
Craft a Compelling Cover Letter: Write a cover letter that directly addresses the job description. Mention your understanding of the role's requirements, your experience with CROs, and how you can contribute to the company's goals in managing clinical trials effectively.
Showcase Your Communication Skills: In your application, provide examples of how you've successfully coordinated with internal teams, sites, and vendors. Highlight any instances where your strong communication skills led to improved project outcomes or resolved challenges.
Highlight Your Proactive Approach: Demonstrate your ability to identify project challenges and propose solutions. Include specific examples from your past experiences where you took initiative to enhance study execution and efficiency.
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.
✨Demonstrate Strong Compliance Knowledge
Familiarise yourself with ICH guidelines, GCP, and relevant regulatory requirements. During the interview, be ready to explain how you've ensured compliance in past roles and how you would approach compliance in this new position.
✨Emphasise Relationship-Building Skills
Since the role involves collaborating with various stakeholders, share examples of how you've successfully built and maintained relationships with clinical trial sites and Principal Investigators. Highlight your communication skills and any strategies you've used to foster these connections.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities and how you handle project challenges. Think of specific instances where you identified risks or issues and the corrective actions you proposed. This will showcase your proactive approach and ability to work independently.
