Senior Site Manager

Johnson & Johnson

Warsaw, Poland
Fully remote
Primary local company contact
Site initiation and start-up
Site monitoring and close-out
This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines

Job Summary

  • This role serves as the primary contact point between the Sponsor and the Investigational Site, ensuring inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines.
  • 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, partnering with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader).
  • The Senior Site Manager will partner with the Local Trial Manager (LTM) and central study team to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site.

Matching Summary

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

Skills & Requirements

Must-have

  • primary local company contact
  • site initiation and start-up
  • site monitoring and close-out
  • risk-based monitoring model
  • site staff training and records
  • recruitment strategy and planning
  • clinical drug supplies management
  • Adverse Events (AE)/Serious Adverse Events (SAE) reporting
  • essential documents in relevant systems
  • trial site preparation for close out
  • good working relationships with investigators
  • proficient therapeutic knowledge

Nice-to-have

  • process improvement and training
  • contribute to process improvement
  • coach and mentor to less experienced site manager
  • special initiatives as assigned
  • Subject Matter Expert

Key Requirements

  • 3-5 years of experience
  • BA or BS degree in Pharmacy, Nursing, Life Sciences or related scientific field
  • 2 years of clinical trial monitoring experience
  • Strong working knowledge of GCP, company SOPs, local laws and regulations
  • Strong IT skills in appropriate software and company systems
  • Willingness to travel with occasional overnight stay
  • Proficient in speaking and writing the country language and English
  • Ability to work on multiple trials in parallel

Work Rights

Not specified

Tailored Resume

Cover Letter