Senior Manager, Clinical Quality Site Oversight (R&D QA)

Manager, Clinical Quality Site Oversight Lead will partner and support the Alnylam CDO to ensure quality and compliance is established and maintained across clinical trial sites globally. Develop robust investigator site quality oversight, including establishment of site Key Quality Indicators (KQIs), to enable global, high-quality clinical trial execution. Monitor risk signal detection, signal management, action planning, and action verification with the Risk Based Quality Management Team for site-level risks across clinical programs. Monitor investigator site performance KQIs across clinical programs and studies (e.g., global and regional trends) and ensure timely escalation and action of identified issues and trends. Monitor Investigator Site File (ISF) KQIs, ensuring compliance and readiness. Partner with TMF team to drive corrective/preventive actions at the process level to ensure inspection readiness at all times. Support Investigator Meeting material, SIV materials, CRA training materials, as requested, and provide training or support to investigator sites in addressing queries pertaining to Quality. Support site-facing template review and development and help facilitate associated process improvement initiatives to ensure robust quality practices are implemented globally. Evaluate and risk assess regulatory intelligence communications to ensure implementation of local and regional GCP requirements (or equivalent) at a site level and from a process (cross-program) perspective in emerging markets/regions. Support Investigator site audits, as requested, and trend on observations and risks for ongoing or upcoming audits. Support site inspection preparation and management activities, as appropriate. Educated in life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent work experience including clinical research, regulatory or quality. Minimum of 6-8 years of relevant experience Experience in quality assurance, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GCP auditing. Understanding of GCP regulations and guidance for FDA, MHRA, PMDA, and International agencies including ICH guidelines. Experience with quality metrics, management of quality events (i.e. serious breach), assessment of GCP compliance, and the application of risk-based thinking.