<h3>Job Description</h3>
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: 
<ul>
<li>Schedule: Full-time</li>
<li>Hours: 40 hours per week</li>
<li>Setting: Remote</li>
</ul>
Responsibilities: 
<ul>
<li>Managing SMs for clinical study site/monitoring activities in compliance with ICH-GCP and SOPs</li>
<li>Partnering with CRO/monitor and LSM to ensure site activation and monitoring readiness</li>
<li>Supporting LSM on monitoring oversight activities such as monitor and site selection and report reviews</li>
<li>Assisting LSM with creating and maintaining monitoring plans and study-specific tools</li>
<li>Facilitating and supporting LSM with SM study-specific training plan and meetings</li>
</ul>
Qualifications: 
<ul>
<li>5+ years of direct Site Monitoring experience in a Biopharmaceutical, Pharmaceutical, or CRO company</li>
<li>Associate's and/or Bachelor's Degree</li>
<li>Strong knowledge of GCP/ICH requirements and country regulatory requirements</li>
<li>Proficient IT skills and adaptability to new applications </li>
</ul>