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- Tasks: Lead clinical operations in early phase oncology and drive innovation in research.
- Company: Excelya, a dynamic company that values audacity, care, and energy.
- Benefits: Inclusive environment, personal growth opportunities, and collaboration with ambitious teams.
- Other info: Fluent in English; French is a plus. Join us and grow together!
- Why this job: Make a real impact in clinical research while developing your career.
- Qualifications: Experience as a Field CRA and a background in life sciences or medical degree.
The predicted salary is between 60000 - 75000 £ per year.
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Pharmacovigilance. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities
- Oversee CRO clinical teams to ensure efficient study start‑up, including feasibility assessments, site selection, and timely completion of regulatory and ethics documentation.
- Ensure all site set‑up and EDC‑related clinical activities are completed on time and in compliance with defined timelines.
- Support and contribute to CRA training, as well as the preparation and delivery of investigator and monitoring meetings in collaboration with cross‑functional teams.
- Assist the study lead and project team in defining study timelines, milestones, and deliverables, ensuring high‑quality and timely execution.
- Prepare, review, and approve key clinical oversight and study documents (e.g. monitoring plans, study manuals, KPIs/KRIs).
- Monitor site performance and risk indicators, review monitoring reports, and ensure appropriate and timely follow‑up of findings.
- Coordinate and manage CRO relationships, including oversight of CRAs/CTLs and participation in RFP and bid defense activities.
- Perform co‑monitoring activities, contribute to study data reviews, and proactively identify and resolve operational issues.
- Ensure timely and accurate data collection, query resolution, and effective coordination of study samples and assessments across stakeholders.
- Conduct regular TMF quality reviews and support audit and inspection readiness and follow‑up activities.
- Act as a company ambassador at investigator sites, building strong relationships while ensuring compliance with GCP, ICH guidelines, and internal SOPs.
Requirements
At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.
Experience: Proven ability to thrive in collaborative, fast‑moving environments.
Skills: Solid background as a Field CRA, with hands‑on monitoring experience especially in Phase I studies, proven experience in CRO oversight, including coordination of study start‑up, monitoring activities, and vendor management.
Education: Life sciences or medical degree, or equivalent qualification.
Languages: Fluent in English (written and spoken), French is a plus.
Clinical Operations Lead Early Phase Oncology employer: Excelya
Contact Detail:
Excelya Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Operations Lead Early Phase Oncology
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, especially those who work at Excelya or similar companies. A friendly chat can open doors and give you insider info on the role.
✨Tip Number 2
Prepare for the interview by diving deep into Excelya's values and recent projects. Show us that you’re not just a fit for the role, but also for our culture of audacity, care, and energy!
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about your past experiences in a structured way, so we can see how you’ve tackled challenges in clinical operations.
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email reiterating your enthusiasm for the role can leave a lasting impression. And remember, apply through our website for the best chance!
We think you need these skills to ace Clinical Operations Lead Early Phase Oncology
Some tips for your application 🫡
Show Your Passion: When writing your application, let your enthusiasm for clinical operations and oncology shine through. We want to see that you’re not just ticking boxes but genuinely excited about the role and what we do at Excelya.
Tailor Your CV: Make sure your CV is tailored to highlight your relevant experience in CRO oversight and Phase I studies. We love seeing how your background aligns with our needs, so don’t be shy about showcasing your achievements!
Be Clear and Concise: Keep your application clear and to the point. We appreciate well-structured applications that make it easy for us to see your qualifications and fit for the role. Avoid jargon unless it’s relevant to the position!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Excelya
✨Know Your Stuff
Make sure you brush up on your knowledge of early phase oncology and the specific responsibilities outlined in the job description. Familiarise yourself with key terms like CRO oversight, GCP, and ICH guidelines. This will show that you're not just interested in the role but also understand the nuances of the industry.
✨Showcase Your Collaborative Spirit
Excelya values collaboration, so be ready to share examples of how you've worked effectively in teams. Think about times when you’ve contributed to CRA training or coordinated with cross-functional teams. Highlighting these experiences will demonstrate that you embody their core values.
✨Prepare Questions
Interviews are a two-way street! Prepare thoughtful questions about the team dynamics, study timelines, and how they measure success in this role. This not only shows your interest but also helps you gauge if the company culture aligns with your own values.
✨Be Ready for Scenario-Based Questions
Expect to face scenario-based questions that assess your problem-solving skills and ability to handle operational issues. Think through potential challenges you might encounter in the role and how you would address them. This will help you articulate your thought process clearly during the interview.