Clinical Operations Educator - Remote

MSD•Rahway, NJ

8d•Remote

About The Position

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.

Requirements

Bachelor's degree in science (or equivalent e.g. nursing qualification)
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.
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 globally and deliver training sessions as needed.
Demonstrated knowledge of how people learn and the ability to use various instructional approaches to enhance learning outcomes.
Demonstrated teamwork and leadership skills across organizational levels.
Ability to embrace change/improvement.
Demonstrated ability to analyse, interpret and solve problems.
Accountability
Adaptability
Business Processes
Clinical Data Management
Clinical Development
Clinical Research
Clinical Site Management
Clinical Trial Management Processes
Clinical Trials
Clinical Trials Operations
Communication Management
Cultural Diversity
Decision Making
Drug Development
Good Clinical Practice (GCP)
Information Retention
Leadership
Nursing
Quality Management
Quality Standards
Regulatory Compliance
Regulatory Requirements
Regulatory Submissions
Risk Based Monitoring

Nice To Haves

Advanced degree, (e.g., master's degree, M.D., PhD)
1 year CRM experience

Responsibilities

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.