Job Details

Clinical Operations Educator

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 inclinical 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.

Main 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.

Qualifications, Skills & Experience

Required Educational Requirements:

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

Preferred Educational Requirements:

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

Required Experience:

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.

Preferred Experience:

1 year CRM experience

Required Knowledge and Skills:

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 analyze, interpret and solve problems.

Extent of Travel: up to 40%

Note: remote positions, 3 openings: 1 based the Americas (North America or Latin America), 1 based in Europe and 1 based in Asia Pacific. Candidate can be based in any GCTO footprint country.

U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is $139,600.00 - $219,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include 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.