Risk-Based Quality Management (RBQM) Specialist
General Summary
The RBQM Centralized Monitoring Specialist is a highly skilled, detail-oriented individual who can lead the development, implementation, and continuous improvement of a comprehensive Risk-Based Quality Management (RBQM) and centralized monitoring program. This role will be instrumental in aligning our clinical trial oversight strategies with the TransCelerate RBQM framework, ensuring proactive risk identification, mitigation, and data-driven decision-making throughout the study lifecycle.
Specific Duties and Responsibilities
RBQM Program Development & Execution
•Design and implement RBQM strategies in accordance with TransCelerate’s methodology, including risk assessment, risk control, risk review, and risk reporting. *
•Lead cross-functional teams in the development of study-specific Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and risk mitigation plans. *
•Facilitate initial and ongoing risk assessments using tools such as RACT (Risk Assessment Categorization Tool). *
•Ensure integration of RBQM principles into protocol design, monitoring plans, and data management strategies. *
Centralized Monitoring
•Develop and manage centralized monitoring processes to identify data trends, anomalies, and potential risks across clinical sites. *
•Collaborate with data management and biostatistics teams to define algorithms and dashboards for real-time data visualization and risk detection. *
•Interpret centralized monitoring outputs to guide targeted site monitoring and recommend corrective actions. *
Cross-Functional Collaboration
•Serve as a subject matter expert (SME) for RBQM and centralized monitoring across clinical development teams. *
•Provide training and guidance to internal stakeholders on RBQM principles and tools. *
•Partner with Clinical Operations and Clinical Quality to ensure compliance with ICH E6(R2), GCP, and regulatory expectations. *
Continuous Improvement & Innovation
•Monitor industry trends and regulatory updates related to RBQM and centralized monitoring. *
•Evaluate and implement technology solutions that enhance risk detection and oversight capabilities. *
•Contribute to internal audits and inspection readiness activities related to RBQM and centralized monitoring.
•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
•Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
•Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
•Perform other work-related duties as assigned.
*Indicates an essential function of the role
Required Qualifications
Minimum education and experience
•Bachelor's degree in life sciences, public health, or related field with 5+ years of experience, or equivalent combination of education and experience
Preferred qualifications
•5+ years’ experience in clinical trial operations, quality management, or data analytics.
•Proven experience in developing and implementing RBQM and centralized monitoring programs.
•Strong understanding of TransCelerate RBQM framework and tools (e.g., RACT, QTLs, KRIs).
•Proficiency in clinical trial data systems (e.g., EDC, CTMS, and data visualization platforms).
•Excellent analytical, communication, and project management skills.
•Ability to work independently and collaboratively in a fast-paced environment.
•Strong oral, written and interpersonal communications skills.
•High degree of accuracy and attention to detail.
•Proficiency with MS Word, Excel, and other standard office tools.
Working Conditions
•General office environment.
•May have business travel from 0% - 10%.
•Requires some lifting and moving of up to 10 pounds.
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, daily.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels daily.
Base Pay Range Per Hour: $90.00 - $120.00
Individual compensation will vary based on factors such as qualifications, skill level, competencies, work location and shift, and will increase over time based on meeting performance and business needs.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
About the job
Apply for this position
Risk-Based Quality Management (RBQM) Specialist
General Summary
The RBQM Centralized Monitoring Specialist is a highly skilled, detail-oriented individual who can lead the development, implementation, and continuous improvement of a comprehensive Risk-Based Quality Management (RBQM) and centralized monitoring program. This role will be instrumental in aligning our clinical trial oversight strategies with the TransCelerate RBQM framework, ensuring proactive risk identification, mitigation, and data-driven decision-making throughout the study lifecycle.
Specific Duties and Responsibilities
RBQM Program Development & Execution
•Design and implement RBQM strategies in accordance with TransCelerate’s methodology, including risk assessment, risk control, risk review, and risk reporting. *
•Lead cross-functional teams in the development of study-specific Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and risk mitigation plans. *
•Facilitate initial and ongoing risk assessments using tools such as RACT (Risk Assessment Categorization Tool). *
•Ensure integration of RBQM principles into protocol design, monitoring plans, and data management strategies. *
Centralized Monitoring
•Develop and manage centralized monitoring processes to identify data trends, anomalies, and potential risks across clinical sites. *
•Collaborate with data management and biostatistics teams to define algorithms and dashboards for real-time data visualization and risk detection. *
•Interpret centralized monitoring outputs to guide targeted site monitoring and recommend corrective actions. *
Cross-Functional Collaboration
•Serve as a subject matter expert (SME) for RBQM and centralized monitoring across clinical development teams. *
•Provide training and guidance to internal stakeholders on RBQM principles and tools. *
•Partner with Clinical Operations and Clinical Quality to ensure compliance with ICH E6(R2), GCP, and regulatory expectations. *
Continuous Improvement & Innovation
•Monitor industry trends and regulatory updates related to RBQM and centralized monitoring. *
•Evaluate and implement technology solutions that enhance risk detection and oversight capabilities. *
•Contribute to internal audits and inspection readiness activities related to RBQM and centralized monitoring.
•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
•Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *
•Ensure other members of the department follow the QMS, regulations, standards, and procedures. *
•Perform other work-related duties as assigned.
*Indicates an essential function of the role
Required Qualifications
Minimum education and experience
•Bachelor's degree in life sciences, public health, or related field with 5+ years of experience, or equivalent combination of education and experience
Preferred qualifications
•5+ years’ experience in clinical trial operations, quality management, or data analytics.
•Proven experience in developing and implementing RBQM and centralized monitoring programs.
•Strong understanding of TransCelerate RBQM framework and tools (e.g., RACT, QTLs, KRIs).
•Proficiency in clinical trial data systems (e.g., EDC, CTMS, and data visualization platforms).
•Excellent analytical, communication, and project management skills.
•Ability to work independently and collaboratively in a fast-paced environment.
•Strong oral, written and interpersonal communications skills.
•High degree of accuracy and attention to detail.
•Proficiency with MS Word, Excel, and other standard office tools.
Working Conditions
•General office environment.
•May have business travel from 0% - 10%.
•Requires some lifting and moving of up to 10 pounds.
•Must be able to move between buildings and floors.
•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, daily.
•Must be able to read, prepare emails, and produce documents and spreadsheets.
•Must be able to move within the office and access file cabinets or supplies, as needed.
•Must be able to communicate and exchange accurate information with employees at all levels daily.
Base Pay Range Per Hour: $90.00 - $120.00
Individual compensation will vary based on factors such as qualifications, skill level, competencies, work location and shift, and will increase over time based on meeting performance and business needs.
What We Offer
•A collaborative teamwork environment where learning is constant, and performance is rewarded.
•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.