Risk Based Quality Manager

Neurocrine Biosciences • San Diego, CA

19h

About The Position

Leads and manages Risk Based Quality Management (RBQM) activities for assigned clinical studies across all phases and various clinical development therapeutic areas. Activities include but are not limited to development and oversight of study risk management plans, collaboration with cross functional study team members and relevant stakeholders to apply RBQM principles in support of study oversight, issue resolution, and central monitoring activities.

Requirements

• BA/BS in life sciences or related discipline or RN AND 6+ years of related industry experience, including experience in drug development, clinical operations or RBQM/Risk Management OR Master's degree in life sciences or related discipline AND 4+ years of related experience as described above
• Ability to interpret clinical trial data and analytics to identify risks and support operational decision-making
• Strong organizational and project management skills, with the ability to manage multiple priorities across studies
• Ability to work effectively in a matrixed, cross-functional environment and build productive relationships with study team members
• Demonstrated ability to follow established processes while identifying practical opportunities for improvement
• Proven ability to quickly learn new information and communicate requirements to the appropriate individuals
• Effective verbal and written communication skills, including the ability to clearly communicate observations, risks, and recommendations
• Strong communication and interpersonal skills with a collaborative mindset and the ability to influence cross functional stakeholders
• Solid understanding of Risk Based Quality Management principles and their application within Clinical Operations
• Working knowledge of FDA regulations, ICH guidelines, and GCP requirements relevant to clinical trial conduct, oversight, and RBQM
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Comfortable developing study specific Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and thresholds for central monitoring
• Ability to identify and escalate issues appropriately and follow-through with the corrective actions

Responsibilities

• Acts as the Risk Management Lead at the study level and is responsible for leading the cross functional study team through the development, execution and oversight of study level Risk Management Plans and activities, including:
• Identification of protocol specific critical data and processes during protocol development
• Identification of risks relevant to protocol specific critical data and processes
• Evaluation and ranking of risks
• Implementation of risk control strategies
• Selection of appropriate Key Risk Indicators and Quality Tolerance Limits to support risk oversight
• Guides the study team through planning and execution of RBQM activities for both insourced and outsourced risk management activities in alignment with study objectives, regulatory guidelines, and Neurocrine SOPs
• Supports timely issue identification and resolution through data analytics and cross functional collaboration, escalating to senior leaders when applicable
• Facilitate risk review meetings and discussions with study team members to effectively communicate and discuss findings and facilitate signal verification, analysis, and mitigation strategies
• Supports inspections and internal audits by providing RBQM-related documentation and analysis, in partnership with Clinical Operations and Quality Assurance
• Maintains accurate and up-to-date RBQM documentation in the TMF in alignment with GCP requirements and company standards
• Identifies opportunities to improve RBQM processes, tools, and ways of working within Clinical Operations and share lessons learned and best practices
• Acts as a change agent, champion, subject matter expert, and point of contact for RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit
• Participate in cross-functional initiatives, projects, or working groups that support continuous improvement of RBQM and clinical trial oversight practices.
• May serve as a mentor to less experienced RBQM colleagues
• May be required to support central monitoring activities, including the development of Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and thresholds for central monitoring
• May carry out other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level