Site Monitoring Lead Job at Tandym Group, Woburn, MA

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  • Tandym Group
  • Woburn, MA

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

Job Tags

Full time, Remote work,

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