Job Description

Overview

The Site and Monitoring Health Lead (SMH Lead) will apply knowledge of regulations and GCPs as well as experience in monitoring to safeguard the quality of clinical trial execution at investigator sites and ensure Alnylam’s oversight of CRO monitoring effectiveness. This is a site-facing position that reports to the Associate Director, Site and Monitoring Health or above.

Summary of Key Responsibilities

• Implement Alnylam’s Site and Monitoring Health strategy in alignment with ICH GCP E6 and E8
• Employ risk-based thinking to focus on what is critical to quality, and exhibit an “inspection ready at all times” mentality
• Create Study Specific Oversight Plans (SSOP) for aligned trials in scope and/or follow SSOP when conducting oversight activities
• Implement various types of oversight encounters and activities as applicable including but not limited to: site risk analysis, site contacts, aggregate review of data, monitoring visit report review, Sponsor Oversight Visits, system/data spot checks, and periodic summaries; ensure timely documentation of these activities is completed and filed
• Build relationships with investigators and site staff in region; act as a resource for identifying potential sites for new studies
• Utilize root cause analysis to assess identified issues and provide suggested actions to Study Management / CRO to mitigate risk
• Support investigator sites less experienced in research; assist in assuring sites are engaged in the study and have what they need to recruit participants successfully
• Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality
• Work closely with Clinical Risk & Analytics staff to understand the risk management plan (Risk MAP) for assigned studies, ensure the SSOP is aligned with the Risk MAP, and assess sites who are outliers
• Lead oversight and trend meetings with the study team and/or CRO to discuss risks, issues, and trends identified by the SMH team for the trial
• Complete administrative tasks (e.g., timesheets, expense reports, Sponsor Oversight Visit reports, etc.) consistently on time and with good quality
• Work independently and collaboratively with cross-functional teams
• Support inspection preparation and management
• Maintain awareness of changes in industry and regulatory standards for GCP requirements
• Travel on assignment is required since this is a site facing position. In general, < 50% travel expected but may have occasional spikes based on business need; local, regional and international travel required

Requirements

• Bachelor's Degree is required. A clinical or advanced degree (e.g. RN, MPH, MS, MA, MBA, PharmD) is preferred
• Previous direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred
• Experience in all study phases of clinical research (Phase I-III; experience in both prevalent and rare medical conditions preferred
• Previous audit support and regulatory inspection experience preferred
• Comprehensive and current regulatory knowledge, including GCPs

Skills

• Demonstrate flexibility in schedule and willingness to travel frequently in assigned region
• Excellent interpersonal, verbal, and written communication skills
• Fluency in multiple languages and cultural awareness is a plus
• Ability to build and maintain relationships with key investigators and sites (e.g. key networks, key trial sites and investigators, key opinion leaders and their site staff
• Innovator, willing to initiate changes, introduce new ideas, and creatively problem-solve
• Experience with Microsoft based applications and ability to learn internal and external computer systems
• Good organizational skills and ability to deal with competing priorities
• Analyze complex situations and effectively communicate issues along with potential recommendations to various functional groups
• Demonstrate good judgment and decision-making experience

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

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