Associate Clinical Quality Operations Manager, Oncology III
New
M
Merck & Co., Inc.Pharmaceutical / Clinical Research
United StatesFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum 4 years of experience
- Required Skills
- Project ManagementQuality AssuranceRisk Management
Requirements
- Bachelor's or Master's degree in healthcare, life sciences, or related field.
- Minimum 4 years of experience in the pharmaceutical industry and/or clinical research.
- Strong knowledge of Good Clinical Practice (GCP) and ICH guidelines.
- Understanding of FDA regulations and EMA Clinical Trial Regulations.
- Experience with Quality Management Systems (QMS).
- Proven experience conducting root cause analysis and managing CAPAs.
- Proficiency in clinical trial processes and risk management methodologies.
- Strong project management and organizational skills.
- Excellent verbal and written communication skills.
- Ability to influence stakeholders and lead cross-functional teams.
Responsibilities
- Support Clinical Trial Teams in embedding Quality by Design (QbD) principles.
- Conduct quality control activities to identify study risks, process gaps, and quality issues.
- Monitor critical data and processes throughout the clinical trial lifecycle.
- Support regulatory inspections, participate in Inspection Support Teams, and track CAPAs.
- Assist with audit preparation, facilitation, root cause analysis, and response development.
- Provide oversight for clinical research vendors and suppliers to ensure compliance.
- Contribute to process innovation and continuous quality improvement initiatives.
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