Clinical Operations Educator – Remote

Job Description

We are seeking three experienced and highly motivated individuals to join our team for a Clinical Operations Educator position. As Clinical Operations Educator you will be fully dedicated to training and education activities supporting the monitoring roles in clinical operations e.g. Clinical Research Associate (CRAs), Clinical Research Managers (CRMs), in the Global Clinical Trial Operations (GCTO) Regions in alignment with strategic priorities for the Regions, supporting an organization of more than 4000 FTEs.

This role focuses on creating role-based, therapeutic area-specific, and process and system training materials and delivering them through live, virtual, or recorded sessions to support GCTO Regions.

You will work collaboratively within the Monitoring Excellence team and engage with key stakeholders across GCTO to ensure training curricula are effective, through feedback and performance metrics, relevant, and aligned with business objectives.

• Develop Training Materials:
  Create and maintain training content aligned with Global Clinical Development standards and Good Clinical Practices (GCPs) and End to End Monitoring activities, including role-based and therapeutic area-specific modules, monitoring processes, and systems. Maintain training materials in compliance with applicable SOPs, policies, and regulatory requirements.
• Defines and contributes to the development of training strategies for GCTO Regions
• Deliver Training Sessions:
  Conduct and deliver live, face to face, virtual, or recorded Training for GCTO roles as required, ensuring engagement and knowledge retention, including train the trainer sessions as needed.
• Collaborate Cross-Functionally:
  Work closely with our Company’s R&D Learning & Development, subject matter experts, and process owners to design and implement effective training material.
• Collaborates with our Company’s R&D Learning & Development in the development and implementation of role-based training curricula.
• Communications Support:
  Leads and develops communication materials (email, web content, presentations) to support training initiatives and business processes.
• Monitor Training Effectiveness:
  Use metrics, surveys, and feedback tools to assess training impact and identify training needs, areas for improvement adjusting plans as appropriate to deliver improved performance.
• Promote Best Practices:
  Implement and advocate for best practices in training design and delivery, ensuring alignment with company goals and quality standards.
• Ensures that training maximizes competency with performance-based metrics tied to quality results.
• Manages and oversees functional or cross-functional networks of training process owners/subject matter experts.
• Collaborates with GCTO to increase visibility of local training, ensure alignment, avoid duplicity and globalize local training when applicable.
• Provides back-up for Clinical Operations Educators in other Regions as needed.

• Bachelor’s degree in science (or equivalent e.g. nursing qualification)

• Advanced degree, (e.g., master’s degree, M.D., PhD)

• 5 years of experience in clinical research, with mandatory 2 years of CRA experience.
• 6 months of experience delivering training sessions, such as local or country-level training or subject matter expert (SME) training.

• 1 year CRM experience

• Strong knowledge of drug development and clinical trial processes, including relevant standards and documentation.
• Familiarity with FDA Good Clinical Practices, ICH Guidelines, and other major regulatory agencies’ regulations and guidance.
• Experience working in a hybrid environment with international cultural diversity.
• Proficiency with learning technologies and platforms for delivering and tracking training.
• Strong educational and coordination skills with demonstrated success in training delivery.
• Excellent oral and written communication skills and ability to retain the attention of diverse audiences.
• Flexibility to work across different time zones to collaborate…