[Hiring] Quality Risk Manager @Rho Inc

Role Description

Join us in redefining what it means to work for a CRO. When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

We are currently hiring a Quality Risk Manager to join our team! The Quality Risk Management (QRM) function is key to driving successful project implementation of a Risk-Based Quality Management (RBQM) strategy. The QRM team will work with the project team to:

• Facilitate project risk assessments
• Develop and maintain the Integrated Quality Risk Management Plan (IQRMP)
• Facilitate strategic quality review meetings
• Perform ongoing centralized monitoring reviews

The QRM team is responsible for ensuring project teams develop an integrated quality risk management strategy in compliance with ICH E6R2 guidelines.

What you'll be doing:

• Risk-Based Quality Management (RBQM) Leadership
  • Manages project-level RBQM activities and documents for multiple projects
  • Facilitates and leads study-specific risk assessments and suggests appropriate anticipated risks and mitigations
  • Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution
  • Ensures project teams develop an integrated quality risk management strategy in compliance with ICH E6R3 guidelines
  • Participates in ongoing RBQM process and tool optimization activities
• Quality Risk Planning & Documentation
  • With minimal supervision, develops and maintains Integrated Quality Risk Management Plan (IQRMP) and Quality Risk Log for assigned studies in coordination with cross functional team
  • Documents observations and actionable items noted during reviews; investigates trends, issues, and risks for root cause
  • Documents completion of activities via tracking, reporting, and/or other required project documents as per SOP
• Data Review & Risk Monitoring
  • Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution
  • With minimal supervision, reviews study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, potential or suspected scientific misconduct, or other systematic errors that could impact data integrity and subject safety
  • Immediately communicates and escalates serious issues to the relevant project team member(s) and, with guidance, develops action plans
  • Initiates set-up and provides inputs needed for Key Risk Indicator (KRI) visualizations, using either a technology platform or an alternate tool
• Regulatory Compliance & Standards
  • Applies knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
  • Keeps up with industry trends, including changes to regulations or standard practices
  • Ensures adherence to compliance standards across all RBQM activities
• Project & Stakeholder Management
  • For assigned activities, understands project scope, budgets, and timelines; manages study activities to ensure project objectives, deliverables, and timelines are met
  • Attends sponsor kick-off meetings and may attend Investigator Meetings
  • Participates in project staff meetings as applicable
  • Coordinates and manages cross-functional activities and responsibilities for assigned study teams (i.e., RCAT input/review, preparations for SQRMs, etc.)
  • Collaborates with study team management to define and enforce compliance with Rho RBQM processes and contracted activities
• Training, Mentorship & Team Development
  • Attends clinical training sessions according to the project-specific requirements
  • May support training and mentoring of Associate QRM
• Audit & Continuous Improvement
  • Supports internal and sponsor audits and participates in efforts to ensure readiness
  • Identifies opportunities for process improvements and communicates to RBQM leadership

Qualifications

• Bachelor Degree in science or a related field
• 3 years of industry experience
• Applicable experience in one or more of the following in a clinical research setting: clinical monitoring, data management, biostatistics, or related function; and/or at least 1 year of strong performance in an AQRM role
• Sound knowledge of Good Clinical Practice/ICH E6 (R3) Guidelines, Risk-Based Monitoring strategies, processes and tools and/or other applicable regulatory requirements and industry trends
• Basic knowledge of clinical data collection, monitoring, and review processes
• Solid understanding of the entire clinical data lifecycle, from protocol creation through database lock and analysis
• Able to quickly adapt to changing priorities to achieve goals/targets
• Able to assess and implement protocol-specific Quality Management approaches as needed, while collaborating with the appropriate impacted functions
• Ability to maintain confidentiality
• Proactively takes initiative to identify next steps, issues, or gaps, and drive tasks forward with minimal guidance
• Ability to set priorities and manage multiple projects within moderate oversight
• Ability to work independently, prioritize responsibilities, and work in a team environment
• Demonstrates strong computer skills and is able to embrace new technologies
• Strong competency with MS Excel functionality (sorting, filtering, calculations, pivot tables)
• Proficiency with Analytical Data Visualization Tools
• Demonstrates the ability to think critically, problem solve and apply sound judgment and reasoning for assigned tasks
• Communicates clearly and professionally in written and verbal formats with both internal and external stakeholders, translating moderate-to-complex concepts into clear, actionable messages
• Solid presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Expected required travel 15% on average

Benefits

• Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k)
• Paid time off, holidays, parental leave and bereavement leave
• Encouragement of work-life balance