Clinical Quality Operations, Oncology

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• The Clinical Quality Operations Manager is responsible for the strategic implementation of 'quality by design' principles within designated clinical trials.

• The CQOM will collaborate with the Clinical Trial Team (CTT) to create Risk Assessment and Categorization Tools, along with Quality Plans.

• CQOMs in a specific therapy area will periodically (e.g., quarterly) conduct a TA-level review of quality plans and risk mitigation strategies to identify any emerging signals or trends and provide pertinent feedback to the CQOL and the Head of CQO as necessary.

• The CQOM will manage and oversee responses to audit and inspection findings as required.

• Additionally, the CQOM will partner with colleagues to analyze data across therapy areas to detect signals and trends, subsequently developing and implementing suitable process improvement strategies.

• In collaboration with the CQOL, the CQOM will cultivate skillsets to recognize and effectively respond to new and emerging risks utilizing technology.

⛳️ Requirements

• A minimum of 6 years of experience in clinical research, including at least 2 years focused on developing and managing clinical quality systems and overseeing regulatory inspections.

• In-depth knowledge and understanding of clinical development programs, clinical trial processes, as well as quality management systems and quality control tools.

• Extensive expertise in Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines and global Regulatory Health Authority requirements.

• Proven experience in delivering effective Corrective and Preventive Action (CAPA) management solutions.

• Familiarity with risk management tools and processes within the clinical quality framework.

• A B.A./B.S. or M.A./M.S. degree or equivalent in a relevant healthcare discipline. Additional formal education in quality management or business management is preferred.

🏝️ Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate and sick leave days.