Senior Manager, Clinical Monitoring Oversight

Shionogi Inc. (U.S.)

Senior Manager responsible for clinical monitoring oversight at Shionogi Inc. Collaborating with cross-functional teams to ensure quality and integrity of risk-based monitoring.

Posted 5/22/2026full-timeRemote • New Jersey • 🇺🇸 United StatesSenior💰 $135,000 - $165,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical research monitoringclinical trial experiencerisk-based monitoring strategiesGCP regulationsreviewing clinical monitoring reports

Soft Skills

communication skillspresentation skills