Headquartered in Kenilworth, New Jersey, Merck is a global pharmaceuticals company offering products that include biologic therapies, vaccines, prescription med
Clinical Quality Operations, Oncology III
Location
Canada
Posted
7 days ago
Salary
$142.4K - $224.1K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Clinical Quality Operations, Oncology III
Merck
Role Description Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. It is business critical that our Company receives consistent, accurate, high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed. The incumbent will be accountable for the development of quality plans to implement `quality by design` within clinical development programs, using a risk-based approach. The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections. Qualifications - 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. 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. Benefits - Comprehensive package of benefits including medical, dental, vision healthcare and other insurance benefits (for employee and family). - Retirement benefits, including 401(k). - Paid holidays, vacation, and compassionate and sick days. Other Activities - Provides input into GCP Quality and Compliance Council. - Assesses and provides input to strengthen company programs/strategies (e.g. QCV) with an aim to increase Inspection Readiness. - Leads, drives, facilitates and/or supports remediation, prevention activities as process improvement and training, as needed. Skills - Superior oral and written communication skills in an international environment. - Excellent project management and organizational skills. - Excellent teamwork and leadership skills, including conflict resolution expertise and discretion. - Ability to lead cross-functional teams of business professionals within and outside our Research division. - Able to act urgently for worldwide health authority inspection matters. - Ability to analyze, interpret and solve complex problems. - Ability to think strategically, critically, and objectively with creativity and innovation. Required Skills - Adaptability - Clinical Quality Management - Clinical Study Design - Clinical Trials Monitoring - Data Analysis - Emerging Risks - Good Clinical Practice (GCP) - Process Improvement Projects - Regulatory Compliance - Regulatory Inspections - Risk Management - Stakeholder Relationship Management - Strategic Thinking - Training and Development Preferred Skills - Oncology
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