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

Alnylam Pharmaceuticals

About The Position

The Clinical Site Quality Oversight Lead supports the execution of quality oversight activities designed to monitor and drive improvements in clinical investigator site quality performance across programs. This position works closely with colleagues responsible for study management; Clinical Operations; Data Sciences Statistics and Epidemiology (DSSE); Clinical Research; etc. Collectively referred to as the Clinical Development Organization (CDO). The Sr. 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. This role will also work in close collaboration with with program/study GCP Program Leads, the R&D Quality Process Improvement team, as well as the Quality Analytics and Insights team. This role is laser focused on cross-program, global, investigator site quality and compliance.

Requirements

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.

Responsibilities

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.
Proactively identify site-specific (cross-program) quality issues or trends, ensure timely escalation, and effectively resolve emerging risks, in collaboration with GCP Program Leads, who manage study-specific compliance issues and risks.
In collaboration with the GCP QA Leads, identifying critical aspects and helping to develop the integrated Data Quality Plans (iDQP).
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.
Partner with Quality Analytics and Insights to develop Alnylam-facing dashboards via data integration or data shuttling from clinical trial systems to support the quality oversight of items including but not limited to major and minor protocol deviations, open/aging monitoring issues, detections delays, and data entry timeliness.
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. For example, helping to identify key risks or data points and make recommendations on sites of interest.
Define and guide global strategy and governance for investigator site systems across studies. Oversee these site systems in alignment with ICH GCP E6(R3) requirements.

Benefits

comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match
Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
We also offer generous family resources and leave.

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