The role of Clinical Trainer is to deliver and implement training for Japanese employees and all levels of leaders in accordance with adult learning principles and appropriate standard operating procedures and regulatory guidelines (where applicable). Collaborates both face-to-face and virtually with other members of the Clinical Operations, Global Site Services and Project Management to ensure business objectives are met through effective learning solutions. Ensures the integrity, consistency, and quality of the work or trainees.
- Develop and deliver clinical research training in a variety of formats (virtuals, workshops, etc.) as well as on-site training courses, predominantly for the Clinical Operations team
- Develop and deliver a broad spectrum of training – including clinical foundation trainings, CRA and CR Assistant training, including ICH-GCP, and various others
- Develop and customize material to fit the Japanese learning and clinical research environment
- Partners with subject matter experts to ensure training content meets Japanese knowledge needs and gaps.
- Performs needs assessments in a collaborative effort with functional leaders and process owners to define training needs and gaps.
- Designs training specifications and objectives and develop internal training programs associated with assigned areas and subject matter.
- Serves as Train-the-Trainer instructor to ensure consistent content delivery.
- Perform follow-up after training courses and gather feedback from course participants; develops training evaluations and assessments; track and produce reports and metrics associated with training activities and performance measures.
- Ensures that all training materials are up-to-date
- Initiates and participates in communications with other relevant training functions (HR, QC, QA, etc.) to ensure synergy of the over-all training process and goal alignment.
- University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
- Thorough knowledge of ICH Guidelines and GCP including clinical training experience
- Thorough understanding of the drug development process.
- Committed to staying abreast of scientific developments and maintaining technical expertise
- Possess highly effective verbal and writing skills along with dynamic and fluent presentation skills
- Demonstrate proficiency in MS Word, Excel, PowerPoint and Outlook
- Fluent in English and Japanese
- At least 5 years of clinical research experience, e.g. as Clinical Research Associate or Project Manager in the CRO or Pharmaceutical industry
- Relevant experience in developing and delivering training in the field of clinical research
- Experience as a Senior Clinical Research Associate, whether internal or external.
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