Sr. Manager, Site and Monitoring Health Lead

Implement Alnylam's Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8 Apply risk-based principles to focus on critical-to-quality factors and maintain an "inspection ready at all times" mindset Support SMH colleagues and FSP SMH Leads in assessing CRO monitoring effectiveness across the portfolio Develop and/or follow Study-Specific Oversight Plans (SSOPs) for assigned trials Conduct oversight activities such as site risk analysis, site contacts, data reviews, monitoring report reviews, Sponsor Oversight Visits, system/data spot checks, and periodic summaries Document oversight activities in a timely and high-quality manner Build and maintain strong relationships with investigators and site staff; support site identification and engagement Conduct root cause analysis on issues and provide mitigation recommendations to study teams and CROs Support research-naïve or less experienced sites to ensure readiness and recruitment success Collaborate with Clinical Risk & Analytics to align SSOPs with the study risk management plan (Risk MAP) Lead trend and oversight meetings with study teams and/or CROs to review risks, issues, and findings Complete administrative responsibilities including visit reports, timesheets, and expenses on time and to standard Participate in cross-functional initiatives and contribute to the evolution of Clinical Operations processes Support inspection readiness and maintain awareness of evolving GCP standards Bachelor's degree required; advanced or clinical degrees (e.g., RN, MPH, MS, MBA, PharmD) preferred Significant experience in clinical research, including direct site monitoring; Lead CRA or monitoring oversight experience preferred Experience with global clinical trials across Phases I-III; rare disease experience is a plus Familiarity with audit and regulatory inspection processes Strong knowledge of GCP and regulatory requirements Prior experience onboarding or mentoring team members in a matrix environment Excellent communication and collaboration skills Strong analytical and problem-solving abilities Ability to work independently and in cross-functional teams Strong organizational skills and ability to manage competing priorities Proficient in Microsoft Office and able to learn new systems quickly Multilingual skills and cultural awareness are an advantage Ability to present complex issues concisely to stakeholders and senior leaders