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, Part time, Remote work,

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