Associate Director, Risk Quality Management; RBQM

Associate Director, Risk Based Quality Management (RBQM)

United States – Remote, United States - California - Foster City Clinical Development & Clinical Operations Regular.

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Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high‑quality clinical data that supports global registration and commercialization of Gilead’s products.

Residing within Clinical Operations, Risk Based Quality Management (RBQM) Strategy & Operations is responsible for implementing RBQM in support of the Gilead portfolio. The Associate Director, RBQM is responsible for timely and high‑quality risk‑based quality management activities. Reporting to the Head of RBQM, this role contributes to the development, usage, and health of the central monitoring capabilities and leads study teams in implementing RBQM principles.

• Provide expert guidance, training, and support on RBQM in clinical trials, ensuring adherence to ICH GCPs, regulatory requirements, and internal processes.
• Advise study teams throughout risk management activities, fostering cross‑functional collaboration, and promoting excellence in risk management.
• Contribute to the development of new central monitoring tools to address risks and support study oversight.
• Contribute to the identification and definition of Quality Tolerance Limits, risks, thresholds, mitigations, and performance indicators.
• Participate in determining monitoring strategies and mitigation plans aligned with study and site risks, including authoring the Central Monitoring Plan.
• Facilitate cross‑functional risk review meetings with study teams, collaborating in risk signal interpretation and triage, ensuring effective communication and resolution of issues.
• Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation.
• Support the development and implementation of data analytical tools used for central monitoring.
• Provide technical expertise to set up and test study‑level central monitoring analytics.
• Map, manage, and design RBQM data flows to integrate with other relevant clinical and operational databases at study, program, and enterprise level.
• Review central monitoring analytics and assist with the investigation of signals and actions, including review system outputs, propose suggestions for signal and action management, and follow up with study team for the action resolutions.
• Identify and interpret anomalies and monitor trends indicative of systematic errors and potential study, site, country, and/or study issues.

• Serve as a Subject Matter Expert and Process Owner for assigned areas, processes, and technologies.
• Contribute to the development, enhancement, and implementation of RBQM processes, systems, templates, tools, and training…