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 SOPsPartnering with CRO / monitor and LSM to ensure site activation and monitoring readinessSupporting LSM on monitoring oversight activities such as monitor and site selection and report reviewsAssisting LSM with creating and maintaining monitoring plans and study-specific toolsFacilitating and supporting LSM with SM study-specific training plan and meetingsQualifications :
5+ years of direct Site Monitoring experience in a Biopharmaceutical, Pharmaceutical, or CRO companyAssociate's and / or Bachelor's DegreeStrong knowledge of GCP / ICH requirements and country regulatory requirementsProficient IT skills and adaptability to new applications