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Site Monitoring Lead
Site Monitoring LeadTandym Group • Woburn, MA, US
Site Monitoring Lead

Site Monitoring Lead

Tandym Group • Woburn, MA, US
3 days ago
Job type
  • Full-time
Job description

Job Description

A pharmaceutical company in Massachusetts is currently seeking a new Site Monitoring Lead to join their team in a remote capacity. In this role, the Site Monitoring Lead will be responsible for developing the study's monitoring strategy and serving as the primary point of contact for all study-specific questions from internal teams and, when applicable, the CRO monitoring team.

About the Opportunity :

  • Schedule : Full-time
  • Hours : 40 hours per week
  • Setting : Remote

Responsibilities :

  • Managing SMs for clinical study site / monitoring activities in compliance with ICH-GCP and SOPs
  • Partnering with CRO / monitor and LSM to ensure site activation and monitoring readiness
  • Supporting LSM on monitoring oversight activities such as monitor and site selection and report reviews
  • Assisting LSM with creating and maintaining monitoring plans and study-specific tools
  • Facilitating and supporting LSM with SM study-specific training plan and meetings
  • Qualifications :

  • 5+ years of direct Site Monitoring experience in a Biopharmaceutical, Pharmaceutical, or CRO company
  • Associate's and / or Bachelor's Degree
  • Strong knowledge of GCP / ICH requirements and country regulatory requirements
  • Proficient IT skills and adaptability to new applications
  • Create a job alert for this search

    Site Lead • Woburn, MA, US

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