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 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
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Shionogi Europe. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Shionogi Europe.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Shionogi Europe. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Shionogi Europe is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Manager, Clinical Monitoring Oversight
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Shionogi Europe!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Shionogi Europe that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Shionogi Europe!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Shionogi Europe, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Shionogi Europe
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Shionogi Europe that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Shionogi Europe’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
