Manager, Risk-Based Quality Management

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 Cambridge, MA. Pay and Benefits The pay range for this position is $145000.00 - $145000.00/hr. 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) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jun 19, 2026. 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. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.