Senior Manager, Clinical Monitoring Oversight
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Job Description
Senior Manager responsible for clinical monitoring oversight at Shionogi Inc. Collaborating with cross-functional teams to ensure quality and integrity of risk-based monitoring.
Responsibilities:
- Responsible for the overall oversight of clinical studies
- Developing comprehensive QCO Plans in collaboration with Clinical Trial Managers
- Supporting study risk assessments and defining RBQM study needs and strategies
- Maintaining and improving standard operating procedures related to clinical monitoring
- Presenting QCO roles and procedures to study teams and CROs
- Overseeing monitoring deliverables such as Monitor Visit Reports and CTMS data
- Conducting site visits and presenting findings
Requirements:
- Bachelor’s degree in a relevant field
- At least 8 years minimum experience in clinical research monitoring
- A minimum of 5 years clinical trial experience within a pharmaceutical, biotechnology, or CRO required in a role leading others
- Strong knowledge of GCP regulations (e.g., US, EU, JP)
- Familiarity with risk-based monitoring strategies and tools
- Strong working knowledge of clinical systems: CTMS, EDC, eTMF, eCOA
- Proficient at reviewing and interpreting clinical monitoring reports
- Strong written and verbal communication skills
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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