Senior Local Trial Manager

Johnson & Johnson

Porto Salvo, Portugal
Local management of clinical trial
Operational oversight of assigned protocol
Delivery of quality data and trial documents
This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries, with operational oversight from start-up through to database lock and closeout activities

Job Summary

  • This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries, with operational oversight from start-up through to database lock and closeout activities.
  • The Senior, Local Trial Manager is 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.
  • The Senior, Local Trial Manager actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and Associate, Local Trial Managers.

Matching Summary

This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries, with operational oversight from start-up through to database lock and closeout activities.

Skills & Requirements

Must-have

  • local management of clinical trial
  • operational oversight of assigned protocol
  • delivery of quality data and trial documents
  • compliance with GCP and regulatory requirements
  • process improvement and mentoring

Nice-to-have

  • therapeutic knowledge development
  • cross-functional team representation
  • mentoring CTAs, SMs and other LTMs
  • flexible mindset and adaptability

Key Requirements

  • Minimum 2 years of clinical trial management experience or 3-5 years of clinical monitoring experience
  • BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field (or equivalent experience)
  • Minimum of 2 years of leadership experience
  • Proficient in speaking and writing the country language and English language
  • Willingness to travel with occasional overnight stay

Work Rights

Not specified

Tailored Resume

Cover Letter