Manager, Risk-Based Quality ManagementJob DescriptionThe 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 risk management and central monitoring, with support for trial-specific monitoring strategy. For assigned studies, this position serves as the integrated study-level RBQM subject matter expert, combining Clinical Risk Management Lead and Central Monitoring Lead responsibilities to connect risk management strategy, central monitoring execution, Quality Tolerance Limit oversight, and study-level quality insights. This role drives effective risk-based approaches that protect patient safety, ensure data integrity, and enhance operational efficiency in close partnership with internal teams and Contract Research Organizations throughout the clinical trial lifecycle.Responsibilities
- Support a fit-for-purpose Risk-Based Quality Management approach that protects participant safety, supports data integrity, and promotes proactive issue prevention across assigned clinical trials.
- Lead or facilitate cross-functional trial-level risk assessments, including identification of Critical to Quality factors, critical data, critical processes, and key trial-level risks in collaboration with Clinical Operations, Clinical Development, Data Management, Biostatistics, Medical Writing, and other functional stakeholders.
- Develop and maintain trial-specific Risk Assessment and Categorization Tool documentation, or oversee CRO development and revision of equivalent risk management documentation, ensuring risks, mitigation strategies, control measures, ownership, rationale, and key decisions are fully documented, reviewed, approved, and inspection-ready.
- Partner with study teams and CROs or service providers to ensure clinical risk management activities are appropriately executed, documented, and aligned with internal processes, trial-specific plans, and applicable vendor procedures.
- Lead, facilitate, or oversee periodic and ad hoc risk reviews throughout study conduct to assess new, changed, or realized risks, including those arising from protocol amendments, central monitoring findings, quality events, CAPAs, operational trends, or other emerging trial information.
- Facilitate or oversee review of Quality Tolerance Limit findings and deviations from predefined thresholds, supporting root cause assessment, mitigation planning, determination of reportability, and documentation of actions, owners, and due dates.
- Support Functional Area Leads in incorporating risk management outputs into relevant trial plans and contribute to inspection-ready documentation across the study.
- Support study closeout by confirming trial-level risks are appropriately reviewed and closed after final database lock and by ensuring required risk management and QTL information is available for Clinical Study Report development.
- Serve as the Central Monitoring subject matter expert for assigned trials, confirming, executing, and overseeing the trial-specific central monitoring strategy, including applicability, scope, and execution model in alignment with study objectives, identified risks, and RBQM principles.
- Provide RBQM input into the trial-specific monitoring strategy, including risk-based monitoring components such as targeted Source Data Verification, Source Data Review, central monitoring, Key Risk Indicators, Quality Tolerance Limits, data quality analytics, review cadence, escalation pathways, and documentation expectations.
- Partner with Clinical Operations, Monitoring Oversight, Functional Area leads, and CROs or service providers to evaluate whether emerging risks, protocol amendments, central monitoring outputs, QTL findings, or operational trends require updates to the monitoring strategy, Central Monitoring Plan, review cadence, technology requirements, or related study documentation.
- Develop or oversee development and revision of the trial-specific Central Monitoring Plan aligned with protocol design, Risk Assessment and Categorization Tool content, Critical to Quality factors, Key Risk Indicators, Quality Tolerance Limits, planned central monitoring components, review cadence, meeting cadence, rationale, and responsible parties.
- Translate or oversee translation of risk controls, Key Risk Indicators, Quality Tolerance Limits, and other planned central monitoring components into technology requirements or programmed outputs in partnership with Data Management, Biostatistics, Clinical Operations, CROs, vendors, and other functional stakeholders.
- Conduct or oversee central monitoring reviews at the cadence defined in the Central Monitoring Plan, including review of signals, data outputs, trends, outliers, missing or incomplete data, unexpected variability, protocol timing issues, and other anomalies that may affect data quality, participant safety, or trial integrity.
- Perform preliminary signal assessment, assign signals to appropriate Functional Area leads for investigation, and partner with study team members to validate root cause and determine corrective and preventive actions, or oversee CRO performance of these activities.
- Facilitate internal central monitoring review meetings or oversee CRO-led central monitoring review meetings, ensuring discussion of confirmed findings, action owners, due dates, contributors, decisions, and follow-up expectations is clearly documented.
- Track or oversee tracking of central monitoring findings and actions through resolution, follow up with action owners, identify study-level trends, and escalate issues as appropriate to the Clinical Operations Lead, study leadership, or relevant Functional Area leads.
- Support or oversee Quality Tolerance Limit implementation and monitoring by translating plain-language definitions into central monitoring system requirements, supporting programmed output development, reviewing QTL outputs, and contributing to QTL finding discussions and Clinical Study Report inputs.
- Maintain or oversee inspection-ready central monitoring documentation, including Central Monitoring Plans, technology requirements, review outputs, meeting documentation, QTL outputs, action tracking, and Trial Master File filing, as applicable.
Essential Skills
- Bachelors degree or equivalent work experience required, preferably in life sciences, healthcare, or a related field.
- Minimum of 6 years of experience in clinical research, clinical operations, clinical quality, data management, monitoring, or a related field.
- At least 2 years of experience with Risk-Based Quality Management, clinical risk management, central monitoring, risk-based monitoring, or related quality oversight activities.
- Working knowledge of Good Clinical Practice and ICH E6(R2)/E6(R3) guidelines, clinical trial conduct, Trial Master File expectations, and inspection-readiness principles.
- Experience working with clinical systems and data outputs, such as Clinical Trial Management Systems, Electronic Data Capture systems, risk assessment tools, central monitoring platforms, and RBQM technologies such as CluePoints or equivalent systems.
- Demonstrated ability to facilitate cross-functional discussions and collaborate effectively with CROs and service providers.
- Ability to interpret clinical and operational data trends, document decisions clearly, and follow actions through to resolution.
- Strong organizational, analytical, communication, stakeholder management, and problem-solving skills.
- Proficiency in Microsoft Office, including strong skills in Excel.
Additional Skills & Qualifications
- Degree in a life sciences or healthcare discipline is preferred.
- Experience in clinical operations and clinical quality environments.
- Background in central monitoring, risk-based monitoring, or data-driven quality oversight is advantageous.
- Proven ability to manage complex, cross-functional projects and maintain inspection-ready documentation.
- Comfort working with RBQM and central monitoring technologies and adapting to evolving tools and processes.
Work EnvironmentThis role is fully remote and requires the ability to work Eastern Standard Time hours, with a preference for candidates located in the East Coast or Central time zones. The position offers a sustainable workload with an expectation of long-term engagement, and involves close partnership with internal teams and external contractors and CROs using modern clinical systems and RBQM technologies. Work is conducted in a virtual, collaborative environment that emphasizes clear documentation, data-driven decision making, and consistent communication across global study teams. Job Type & LocationThis is a Contract position based out of Cambridge, MA. Pay and BenefitsThe pay range for this position is $145000.00 - $150000.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Job Type & LocationThis is a Contract position based out of Cambridge, MA. Application DeadlineThis position is anticipated to close on Nov 20, 2026. Workplace TypeThis is a fully remote position.About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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