Site Monitoring Lead
Bedford, MA
Job Type: Contract | Recruiter: Hillary Bergstrom | Phone: 603-772-2700
Location: Albany, NY (Remote – Local candidates preferred)
Length: 12+ months
Job Description:
Our client is seeking a Site Monitoring Lead (SML) who will collaborate with the Lead Study Manager (LSM) to develop and implement a monitoring strategy for clinical studies. The SML will act as the primary point of contact for study-specific monitoring inquiries and will oversee Site Monitors (SMs) to ensure compliance with protocols, ICH-GCP, and applicable regulations. The SML will assist with site selection, monitor oversight, and risk management throughout the study lifecycle, from start-up to close-out.
Essential Duties and Responsibilities (but not limited to):
- 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 (i.e., ISF reconciliation tool and SM FAQ).
- 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.
- 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 adapt to new technologies).
- 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.
- 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.
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