Sr. Manager, Risk Management RBQM REMOTE

Manager, Risk-Based Quality Management

The Role:

The Manager, Risk-Based Quality Management (RBQM) plays a critical cross-functional role in ensuring the quality and compliance of clinical trial execution by leading efforts across all components of RBQM: risk management, central monitoring, and monitoring strategy and oversight.

This role is accountable for driving effective risk-based approaches that protect patient safety, ensure data integrity, and enhance operational efficiency. The Manager partners closely with internal teams and CROs to align execution with risk and quality expectations throughout the clinical trial lifecycle.

Key responsibilities include:

Risk Management Execution

+ Plan and Lead study- and program-level risk assessments and discussions, ensuring Critical to Quality (CTQ) factors, Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and mitigation actions are consistently applied and tracked. Champion risk-based approaches in protocol de-risking, IQRMP development, and issue management.

+ Contribute to development of the Clinical Study Report (CSR) related to Risk Management and Quality Tolerance Limits (QTLs)

+ Draft plain language QTL definitions and fully document parameter, thresholds, and justification

Central Monitoring Leadership

+ Lead and/or oversee centralized monitoring activities, including configuration and review of KRIs, QTLs, and data quality assessments within platforms (e.g., Clue Points).

+ Develop and/or approve central monitoring plan, SDV spec documents, Programming specifications for KRIs/QTLs, translate plain language QTL definitions into system requirements and ensure programming and monitoring per plan.

+ Perform UAT/Quality checks on programmed outputs

+ Evaluate and interpret statistical outputs and risk signals, performing initial root cause analysis and proposal of actions.

+ Escalate and present findings and trends, coordinate root cause analysis and remediation with cross-functional stakeholders. Follow actions through to appropriate resolution.

Monitoring Oversight Coordination

+ Serve as the program-level lead for monitoring oversight, ensuring alignment of CRO/site monitoring practices with RBQM strategy

+ Develop and implement Monitoring Oversight Plans and risk-adjusted monitoring approaches (on-site, remote, and centralized).

+ Conduct or oversee on-site or remote oversight visits, review monitoring reports and issue logs and support site and CRO performance evaluation activities.

+ Identify performance or compliance trends at the site, study or vendor level and collaborate with clinical teams to implement corrective actions and quality improvement measures.

Contribute to Continuous Improvement Initiatives and Quality Culture

+ Collaborate with internal and external cross-functional clinical trial teams to ensure alignment between operational practices and RBQM principles.

+ Deliver training and mentorship on RBQM methodologies, tools and oversight expectations.

+ Contribute to continuous improvement of RBQM processes, ensuring alignment with evolving regulatory guidance.

+ Adhere to timelines and requirements for RBQM deliverables.

+ Contribute to audit/inspection readiness by ensuring appropriate documentation of RBQM activities and responses to findings and acting a the RBQM SME during audits/inspections.

+ Promote a proactive, quality-by-design mindset across study teams.

Required Education, Experience,

Certifications:

+ A minimum of 5 years of clinical research experience, including at least 2 overarching RBQM experience.

+ Working knowledge of GCP, regulatory guidelines, and quality risk management practices.

+ Proficiency with Microsoft Office (including Excel), CTMS, EDC, risk assessment tools and centralized monitoring platforms.

+ Strong analytical, communication and organizational skills with a strong attention to detail.

Work Environment

This is a remote position operating on East Coast hours. The role requires a commitment of 40 hours per week. The workload is sustainable with long-term renewal expectations, offering a generous PTO and holiday package.

Job Type & Location

This is a Contract position based out of Remote, OR.

Pay and…