Clinical Quality Operations, Oncology

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🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $142.4k - $224.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. • The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT. • The CQOMs within a specific therapy area will collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate. • The CQOM will facilitate and oversee the responses to audit and inspection observations as appropriate. • In addition, the CQOM will work with peers to analyze data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies. • In partnership with the CQOL, the CQOM will develop skillsets in order to be able to recognize and appropriately respond to new and emerging risks through the use of technology.

🎯 Requirements

• Minimum of 6 years in clinical research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections. • Profound knowledge and comprehension of clinical development programs, clinical trial processes as well as quality management systems and quality control tools. • Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements. • Has delivered effective CAPA management solutions. • Has worked with risk management tools and processes within the clinical quality framework. • B.A./B.S. or M.A./M.S. Degree or equivalent in relevant health care area. Further formal education in quality management or business management is preferred.

🏖️ Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family) • retirement benefits, including 401(k) • paid holidays • vacation • compassionate and sick days