Responsibilities
- Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.
- Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.
- Integrate RBQM principles into study planning, execution, oversight, and close-out activities.
- Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy.
- Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.
- Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.
- Oversee centralized risk monitoring and trending to enable early detection of critical risks.
- Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection
- Establish and maintain a centralized Clinical Risk Library, capturing: Known and emerging risks, Root causes, Mitigation strategies, Effectiveness of controls
- Lead lessons learned activities across trials, audits, inspections, and CAPAs.
- Ensure lessons learned are: Systematically captured, Analyzed for trends, Fed back into RBQM planning, SOPs, training, and future studies
- Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness.
- Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.
- Provide centralized quality oversight across trials, CROs, and vendors.
- Support audit and inspection readiness activities, including: Risk-based inspection preparation, Impact assessments, CAPA development and effectiveness checks
- Design and implement risk-based oversight strategies for CROs and external vendors.
- Monitor vendor performance using quality metrics and risk indicators.
- Lead or support quality governance discussions with external partners.
- Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.
- Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.
- Generate enterprise-level risk trend reports and insights for senior leadership.
- Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.
- Champion a culture of proactive quality and continuous improvement across Clinical Operations.
- Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.
- Provide RBQM training and coaching to study teams and cross-functional stakeholders.
- Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.
- Participate as an observing member on assigned study teams to provide real-time quality and risk support.
- Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.
- Support governance activities, senior management reporting, and quality metrics standardization.
- Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field
- 10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM
- Demonstrated experience leading enterprise or cross-study risk management frameworks
- Strong background in audit/inspection readiness, CAPA management, and vendor oversight
- Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
- Expertise with RBQM tools, centralized monitoring systems, and risk analytics
- Experience defining and using KRIs, QTLs, and quality metrics
- Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI)
Nice to Have
- Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science
- Exposure to AI or predictive analytics for quality monitoring
Benefits
- 401K with company match
- Annual Bonus Program (Sales Bonus for Sales Jobs)
- Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
- Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Life & Disability Insurance
- Concierge Services
- Long Term Incentive Program (subject to job level and performance)
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
Work Arrangement
Hybrid
Additional Information
- Requires up to 25% domestic and international travel.
- May involve working outside of regular business hours to accommodate global time zones and project deadlines.
