Site Monitoring Lead

Digital Prospectors - Bedford, MA

Full-time - Mid Level

Remote - Bedford, MA

Professional, Scientific, and Technical Services

About the position

The Site Monitoring Lead (SML) will collaborate with the Lead Study Manager (LSM) to develop and implement monitoring strategies for clinical studies. This role serves as the primary contact for study-specific monitoring inquiries and oversees Site Monitors (SMs) to ensure compliance with protocols, ICH-GCP, and applicable regulations throughout the study lifecycle, from start-up to close-out.

Responsibilities

• Manage Site Monitors (SMs) for clinical study site activities, ensuring compliance with ICH-GCP, local regulations, and sponsor SOPs.
• Provide oversight for monitoring consistency across study sites.
• Support study start-up activities, including Site Qualification Visits (SQV) and Site Initiation Visits (SIV).
• Work with CROs, monitors, and LSM to ensure timely site activation.
• Collaborate with the LSM to develop and maintain monitoring and oversight plans, monitoring trackers, and study-specific tools.
• Facilitate or support sites, monitor training sessions, SM meetings, and onboarding activities.
• Review trip reports, track sites and monitor performance, and escalate risks to the LSM.
• Assist with corrective and preventative actions related to site, SM, and vendor performance.
• Support the LSM in managing regulatory documentation, including CDA, contract status, and site performance metrics.
• Assist with line listing data reviews and updates to site-facing documents.
• Co-monitor study sites when needed and assist with audits and inspections as required.
• Build and maintain positive relationships with site teams, ensuring continuity throughout the study.
• Promote effective communication with internal stakeholders and external study sites.

Requirements

• Bachelor's degree in a health or medical science field (or equivalent).
• Minimum of 5 years of experience in clinical site monitoring within biopharmaceutical, pharmaceutical, or CRO environments.
• Strong understanding of GCP and ICH guidelines and local regulatory requirements.
• Proficiency in clinical documentation and Good Documentation Practices.
• Excellent communication and conflict resolution skills.
• Strong organizational, time management, and problem-solving abilities.
• Proficient in Microsoft Office and clinical IT applications.
• Ability to analyze sites and monitor metrics and implement corrective actions when needed.
• Strong interpersonal skills with the ability to work effectively in a matrix environment.
• Ability to manage multiple tasks and prioritize effectively in a fast-paced, changing environment.
• Independent and accountable, with the ability to set a sense of urgency as needed.
• Demonstrated leadership and decision-making capabilities in a clinical monitoring context.

Nice-to-haves

• Experience in managing or overseeing site monitors is preferred.
• Experience in rare diseases, genetic disorders, and complex therapeutic areas (i.e., oncology, pediatric studies, neurology, cardiovascular, etc.) is preferred.

Benefits

• Medical
• Dental
• Vision
• Life
• Short-Term Disability (STD)
• Long-Term Disability (LTD)
• Paid Time Off (PTO)