Manager, Site and Monitoring Health Lead

Role: Site and Monitoring Health Lead responsible for ensuring quality and compliance in clinical trial site management at Alnylam. Main objectives include implementing risk-based oversight strategies aligned with GCP, maintaining an inspection-ready state, and fostering investigator relationships. Responsibilities encompass developing Study Specific Oversight Plans, conducting oversight activities (e.g., risk analysis, data review, site visits), troubleshooting site issues, supporting less experienced sites, and leading oversight meetings. The role also involves risk assessment, inspection preparation, and administrative tasks, with a focus on monitoring site performance across study phases (I-III) in diverse therapeutic areas, including rare and prevalent conditions. Requirements: Bachelor's Degree (clinical or advanced degrees preferred), prior monitoring experience with CROs or pharma, including multinational studies in phases I-III, and regulatory knowledge of GCPs. Skills include flexibility to travel up to 50%, strong communication, relationship-building with investigators, problem-solving, organizational abilities, and proficiency with Microsoft tools. Preferred qualifications include experience in audit support and site management leadership, fluency in multiple languages, and cultural awareness. The position involves travel (local, regional, international) and reports to the Associate Director, Site and Monitoring Health. It is a site-facing role with a focus on risk management, oversight planning, and fostering investigator collaboration to support trial integrity and quality.