At a Glance
- Tasks: Lead quality oversight in clinical trials and ensure compliance with high standards.
- Company: Shionogi, a purpose-driven company focused on global health innovation.
- Benefits: Empowering environment, cross-functional collaboration, and opportunities for impactful contributions.
- Other info: Fast-paced, collaborative culture with opportunities for travel and professional growth.
- Why this job: Make a real difference in clinical trial quality and patient outcomes.
- Qualifications: Experience in clinical monitoring and strong analytical skills required.
The predicted salary is between 55000 - 65000 £ per year.
Driving Quality, Oversight and Excellence in Clinical Trials. At Shionogi, we are committed to improving global health through innovation, collaboration and scientific excellence. As we continue to grow our European Development organisation, we are strengthening our clinical capabilities to ensure the highest standards of quality, compliance and execution across our clinical trials.
We are now seeking a Manager, Clinical Monitoring Oversight to play a critical role in ensuring robust oversight of clinical trial delivery and CRO performance across global and regional studies. This is a key position contributing to the integrity, quality and success of our clinical development programmes.
Why Join Shionogi? Shionogi offers a purpose-driven, agile environment where individuals are empowered to make a meaningful impact. This role provides strong cross-functional exposure within global study teams, close collaboration with internal and external partners, and the opportunity to shape and continuously improve clinical monitoring quality and oversight practices.
About the Role: As Manager, Clinical Monitoring Oversight, you will lead and execute Quality Control Oversight (QCO) activities across clinical studies, ensuring that CRO monitoring activities and site performance meet Shionogi’s quality and compliance expectations. In addition, when Shionogi utilises an in-house-monitoring model, you may act as the LCRA/CRA and perform related duties including on-site monitoring visits.
- QCO activities across global and/or regional for assigned clinical trials
- Developing and implementing QCO plans, including study-specific oversight strategies and training materials
- Reviewing CRO monitoring activities, including site performance, patient enrolment and data quality
- Analysing study data, risk indicators and trends to identify quality issues and potential risks
- Partnering with internal teams and CROs to define and implement corrective and preventive actions
- Conducting QCO site visits and ensuring alignment and consistency across study oversight activities
- Supporting study teams with risk management and ongoing quality/process improvement initiatives
What Are We Looking For? We are looking for a detail-oriented and analytical clinical professional who thrives in a collaborative, fast-paced environment and is passionate about ensuring clinical quality and compliance.
You will bring:
- Strong experience in clinical monitoring within pharmaceutical, biotechnology or CRO environments
- Experience in oversight of CRO monitoring activities and/or clinical trial quality management
- Solid understanding of ICH GCP and risk-based monitoring methodologies
- Experience working with clinical systems such as CTMS, EDC and eTMF
- Ability to analyse clinical data, identify trends and drive quality improvements
- Strong communication skills with the ability to influence and collaborate with internal teams and external partners
- A proactive, solution-oriented approach with strong attention to detail and accountability
- Willingness to travel as required
Join Us: Join Shionogi and play a pivotal role in ensuring the quality and integrity of our clinical trials. If you are motivated by driving excellence in clinical oversight and contributing to high-impact development programmes, we would welcome your application.
Manager, Clinical Monitoring Oversight in London employer: Shionogi Europe
At Shionogi, we pride ourselves on fostering a purpose-driven and agile work environment that empowers our employees to make a meaningful impact in global health. As a Manager in Clinical Monitoring Oversight, you will benefit from strong cross-functional collaboration, opportunities for professional growth, and the chance to shape clinical quality practices within a supportive team. Our commitment to innovation and excellence ensures that you will be part of a dynamic organisation dedicated to improving lives through scientific advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Manager, Clinical Monitoring Oversight in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical trials field, attend industry events, and engage on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching Shionogi and understanding their values and mission. We want to see your passion for improving global health and how you can contribute to their clinical monitoring excellence. Tailor your responses to show you’re the perfect fit!
✨Tip Number 3
Showcase your analytical skills! Be ready to discuss specific examples of how you've identified trends or improved quality in past roles. We love hearing about your proactive approach and how you’ve tackled challenges in clinical monitoring.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are eager to make an impact in clinical trials.
We think you need these skills to ace Manager, Clinical Monitoring Oversight in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the job description. Highlight your clinical monitoring experience and any relevant oversight activities you've been involved in. We want to see how you can contribute to our mission!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical quality and compliance. Share specific examples of how you've driven improvements in past roles, and let us know why you want to join Shionogi.
Showcase Your Analytical Skills:Since this role involves analysing study data and identifying trends, make sure to mention any relevant analytical tools or methodologies you've used. We love seeing candidates who can demonstrate their ability to drive quality improvements through data!
Apply Through Our Website:We encourage you to apply directly through our website for a smoother application process. It’s the best way for us to receive your application and ensure it gets the attention it deserves. We can't wait to hear from you!
How to prepare for a job interview at Shionogi Europe
✨Know Your Clinical Stuff
Make sure you brush up on your knowledge of ICH GCP and risk-based monitoring methodologies. Be ready to discuss how you've applied these in previous roles, especially in relation to CRO oversight and clinical trial quality management.
✨Showcase Your Analytical Skills
Prepare examples that highlight your ability to analyse clinical data and identify trends. Think about specific instances where you drove quality improvements or implemented corrective actions based on your analysis.
✨Communicate Effectively
Practice articulating your thoughts clearly and confidently. Since this role involves collaboration with internal teams and external partners, demonstrate your strong communication skills by discussing how you've influenced stakeholders in past projects.
✨Be Proactive and Detail-Oriented
During the interview, showcase your proactive approach to problem-solving. Share examples of how your attention to detail has helped prevent issues in clinical trials or improved oversight practices. This will resonate well with their focus on quality and compliance.
