Senior Manager, Clinical Monitoring Oversight

🕒 May 29

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $135k - $165k / year

⏰ Full Time

🟠 Senior

👔 Manager

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Shionogi Inc. (U.S.)

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Shionogi Inc. (U. S. ) is a pharmaceutical company committed to improving patient lives by developing innovative treatments for challenging diseases. Since its establishment in 1878, Shionogi has focused on addressing global health issues such as antimicrobial resistance and COVID-19, with a strong emphasis on research and development of novel antibiotics and antiviral medications. The company prioritizes scientific excellence and collaboration with various partners to advance healthcare solutions.

📋 Description

• Responsible for the overall oversight of clinical studies • Developing comprehensive QCO Plans in collaboration with Clinical Trial Managers (CTMs) • Supporting study risk assessments and defining RBQM study needs and strategies • Contributing to process excellence by maintaining and continually improving standard operating procedures • Presenting QCO roles and procedures to study teams and CROs • Overseeing and evaluating monitoring deliverables such as Monitor Visit Reports, CTMS data • Conducting site visits, presenting findings, serving as the point of contact for CROs • Performing gap assessments for internal and external SOPs/processes

🎯 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 • Strong knowledge of GCP regulations (e.g., US, EU, JP) • Familiarity with risk-based monitoring strategies and tools (e.g., KRIs, QTLs, central monitoring) • Strong working knowledge of clinical systems: CTMS (e.g., Veeva Vault), EDC, eTMF, eCOA • Proficient at reviewing and interpreting clinical monitoring reports • Strong written and verbal communication skills

🏖️ Benefits

• Equal opportunity employer supporting individuals with disabilities and veterans • Reasonable accommodations for applicants with disabilities