Senior Local Trial Manager

Johnson & Johnson

Toronto, Ontario, Canada
Hybrid
Clinical trial management
Ich-gcp and canadian regulations
Project management skills
The Senior Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities

Job Summary

  • The Senior Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities.
  • Responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
  • Actively contributes to process improvement, training and mentoring of CTAs, SMs and other LTMs.

Matching Summary

The Senior Local Trial Manager is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities.

Skills & Requirements

Must-have

  • Clinical trial management
  • ICH-GCP and Canadian regulations
  • Project management skills
  • Trial Master File management
  • Risk-based trial management

Nice-to-have

  • Leadership and influencing skills
  • Collaboration and conflict resolution
  • Process improvement contribution
  • Mentoring and coaching experience
  • Experience in oncology

Key Requirements

  • Minimum Bachelor of Science or equivalent
  • Minimum 2 years clinical trial management experience
  • In-depth knowledge of ICH-GCP
  • Knowledge of Canadian regulations

Work Rights

Not specified

Tailored Resume

Cover Letter