[innovative Medicine] R&d, Site Manager, Clinical Operations, Gco Japan (leadership Development Program)

Johnson & Johnson UK

Chiyoda, Tokyo, Japan
Fully remote
Gcp and applicable regulations
Site initiation and start-up
Remote monitoring
This role serves as the primary contact point between the Sponsor and the Investigational Site to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations

Job Summary

  • This role serves as the primary contact point between the Sponsor and the Investigational Site to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations.
  • Responsibilities include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities.
  • The Associate, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols.

Matching Summary

This role serves as the primary contact point between the Sponsor and the Investigational Site to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations.

Skills & Requirements

Must-have

  • GCP and applicable regulations
  • site initiation and start-up
  • remote monitoring
  • data entry and query resolution
  • AE/SAE reporting
  • essential documents maintenance

Nice-to-have

  • adapt to change
  • learn proactively
  • embrace new challenges
  • process improvement
  • therapeutic knowledge development

Key Requirements

  • BA or BS degree in Pharmacy, Nursing, Life Sciences, or related scientific field
  • 1 year of clinical trial monitoring experience
  • Basic working knowledge of GCP, company SOPs, local laws, and regulations
  • Proficient in speaking and writing the country language and English

Work Rights

Not specified

Tailored Resume

Cover Letter