Shionogi Europe
Manager, Clinical Monitoring Oversight
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Manager, Clinical Monitoring Oversight
Manager, Clinical Monitoring Oversight – Shionogi (Euro)
At Shionogi, we are committed to improving global health through innovation, collaboration and scientific excellence. As we 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
- The opportunity to shape and continuously improve clinical monitoring quality and oversight practices
About the Role
As Manager, Clinical Monitoring Oversight (QCO), you will lead and execute Quality Control Oversight (QCO) activities across clinical studies, ensuring CRO monitoring activities and site performance meet Shionogi’s quality and compliance expectations.
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When Shionogi utilises an in-house-monitoring model, you may also act as an LCRA/CRA to perform related duties, including:
- On-site monitoring visits
Key Responsibilities
QCO Operations
- Execute QCO activities for assigned global/regional clinical trials
- Develop and implement QCO plans, including study-specific oversight strategies and training materials
- Review CRO monitoring activities (site performance, patient enrolment and data quality)
- Monitor clinical trial site performance and patient safety
Data & Risk Analysis
- Analyse study data, risk indicators, and trends to:
- Identify quality issues
- Assess potential risks
- Partner with internal teams and CROs to:
- Define corrective and preventive actions
- Drive ongoing quality/process improvement initiatives
Study & Team Support
- Conduct QCO site visits to ensure alignment and consistency across oversight activities
- Provide support for risk management and monitoring execution
What We Are Looking For
We are seeking a detail-oriented, analytical clinical professional who thrives in a collaborative fast-paced environment and is passionate about clinical quality and compliance.
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Key Requirements
- Years of industry experience: Strong background in clinical monitoring within pharmaceutical, biotechnology, or CRO environments
- Oversight experience: Proven track record in:
- Oversight of CRO monitoring activities
- Clinical trial quality management
- Regulatory knowledge:
- Solid understanding of ICH GCP
- Experience applying risk-based monitoring methodologies
- Technological skills:
- Familiarity with clinical systems (CTMS, EDC, eTMF)
- Analytical & problem-solving skills:
- Ability to analyse clinical data
- Identify trends and drive quality improvements
- Communication & collaboration:
- Strong stakeholder management
- Ability to influence and collaborate with internal teams and external partners
- Mindset:
- Proactive, solution-oriented approach
- Strong attention to detail and accountability
- Mobility:
- 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.
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