Senior Patient Safety and GxP Training Matrix and Curriculum Manager

Role Summary

Senior Patient Safety and GxP Training Matrix and Curriculum Manager. Lead the design, development, and delivery of comprehensive training programs within the Clinical, Medical, Regulatory (CMR) organization to ensure regulatory compliance and medical affairs capability across global operations.

Responsibilities

• Create job-specific training curricula for different roles within clinical operations, medical affairs, and regulatory affairs
• Maintain training assignments on clinical research documentation, regulatory requirements, Good Clinical Practice (GCP), and medical affairs procedures
• Develop training needs assessments to identify knowledge gaps and learning requirements across CMR functions
• Ensure training materials are compliant with company standards and regulatory requirements
• Develop and deliver training on regulatory guidelines including FDA, EMA, ICH-GCP, and other global regulatory requirements
• Coordinate mandatory compliance training for clinical research staff, including GCP certification and recertification programs
• Support live offerings of SOP training, including logistics, venue booking, materials preparation, technology setup, and participant registration
• Coordinate with subject matter experts (SMEs) to develop and deliver specialized training content for clinical trials, regulatory submissions, and medical communications
• Ensure training programs meet regulatory audit requirements and maintain comprehensive training documentation
• Support preparation for regulatory inspections by ensuring all CMR staff have current and compliant training records
• Stay current with evolving regulatory requirements and update training materials accordingly
• Maintain the Learning Management System (LMS) for CMR training programs, ensuring accurate records of participation and completion
• Generate training reports and analytics to track completion rates, effectiveness, and compliance metrics
• Manage training documentation including attendance records, certificates, and qualification matrices
• Develop and maintain standard operating procedures (SOPs) for training processes and documentation
• Collaborate with CMR subject matter experts to create engaging training materials, presentations, and e-learning modules
• Update existing training content to reflect current regulations, company procedures, and industry best practices
• Monitor training effectiveness through participant feedback, assessments, and performance metrics
• Conduct regular reviews of training programs to ensure relevance, accuracy, and regulatory compliance
• Implement quality improvement initiatives based on feedback and training analytics
• Support internal and external training audits by providing documentation and process information
• Collaborate with Quality Assurance teams to ensure training programs support overall quality management systems

Qualifications

• Bachelor's degree in Life Sciences, Healthcare Administration, Education, or related field
• 7+ years of experience in pharmaceutical training, clinical research, or regulatory affairs
• Strong knowledge of clinical research processes, Good Clinical Practice (GCP), and pharmaceutical regulations
• Experience with Learning Management Systems (LMS) and training administration
• Excellent presentation and facilitation skills with ability to engage diverse audiences
• Strong project management and organizational skills with attention to detail
• Proficiency in Microsoft Office Suite, particularly PowerPoint, Excel, and database management
• Understanding of adult learning principles and instructional design concepts

Skills

• Regulatory training and compliance
• LMS administration and training analytics
• Content development for regulatory, clinical, and medical affairs training
• Quality assurance and continuous improvement in training

Education

• As listed in Qualifications (Bachelor's degree or equivalent)

Additional Requirements

• Approximately 20% overnight travel