Manager, Clinical Monitoring Oversight
Description
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.
Key responsibilities include:
- 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.