Manager, Site and Monitoring Health Lead

Alnylam Pharmaceuticals

5d•$123,300 - $166,800

About The Position

The Site and Monitoring Health Lead (SMH Lead) applies regulatory and GCP knowledge and monitoring experience to safeguard the quality of clinical trial execution at investigator sites and oversee CRO monitoring effectiveness. This is a site-facing role that reports to the Associate Director, Site and Monitoring Health or above. Travel is required, generally expected to be less than 50%, with occasional increases based on business needs; local, regional, and international travel may be required. The SMH Lead implements Alnylam’s Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8, applies risk-based thinking, and maintains inspection readiness. The role develops or follows Study Specific Oversight Plans (SSOPs), conducts and documents oversight activities, builds relationships with investigators and site staff, assesses site and study risks, and partners with study teams, CROs, and Clinical Risk & Analytics staff to address issues and trends. The role also supports less experienced research sites, inspection preparation and management, and administrative activities. Alnylam describes itself as a leader in RNAi therapeutics and highlights its values of fierce innovation, passion for excellence, purposeful urgency, open culture, and commitment to people. The role is eligible for annual short- and long-term incentive awards. The stated U.S. base salary range is $123,300–$166,800. Alnylam offers medical, dental, and vision coverage; life and disability insurance; a lifestyle reimbursement program; flexible spending and health savings accounts; a 401(k) with company match; paid time off, wellness days, holidays, and company-wide recharge breaks; and family resources and leave.

Requirements

Bachelor’s degree required.
Previous direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies.
Experience in all study phases of clinical research (Phase I–III).
Comprehensive and current regulatory knowledge, including GCPs.
Flexibility in schedule and willingness to travel frequently in the assigned region.
Excellent interpersonal, verbal, and written communication skills.
Ability to build and maintain relationships with investigators and sites, including key networks, trial sites, investigators, key opinion leaders, and site staff.
Experience with Microsoft-based applications and ability to learn internal and external computer systems.
Good organizational skills and ability to manage competing priorities.
Ability to analyze complex situations and communicate issues and potential recommendations effectively to various functional groups.
Good judgment and decision-making experience.

Nice To Haves

A clinical or advanced degree, such as RN, MPH, MS, MA, MBA, or PharmD.
Lead CRA or management experience.
Experience in both prevalent and rare medical conditions.
Previous audit support and regulatory inspection experience.
Fluency in multiple languages and cultural awareness.
Ability and willingness to initiate changes, introduce new ideas, and creatively solve problems.

Responsibilities

Implement Alnylam’s Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8.
Use risk-based thinking to focus on critical-to-quality activities and maintain inspection readiness.
Create Study Specific Oversight Plans (SSOPs) for aligned trials in scope and/or follow SSOPs when conducting oversight activities.
Implement applicable oversight encounters and activities, including site risk analysis, site contacts, aggregate data review, monitoring visit report review, Sponsor Oversight Visits, system/data spot checks, and periodic summaries; ensure activities are documented and filed on time.
Build relationships with investigators and site staff in the region and help identify potential sites for new studies.
Use root cause analysis to assess identified issues and recommend actions to Study Management and/or CROs to mitigate risk.
Support investigator sites with less research experience and help ensure sites are engaged and equipped to recruit participants successfully.
Troubleshoot and use alternative, innovative approaches to address problems affecting clinical site delivery and quality.
Work with Clinical Risk & Analytics staff to understand assigned studies’ Risk MAPs, align SSOPs with Risk MAPs, and assess site outliers.
Lead oversight and trend meetings with study teams and/or CROs to discuss risks, issues, and trends identified by the SMH team.
Complete administrative tasks, including timesheets, expense reports, and Sponsor Oversight Visit reports, consistently and on time.
Work independently and collaboratively with cross-functional teams.
Support inspection preparation and management.
Maintain awareness of changes in industry and regulatory GCP standards.