Quality Risk Manager

Rho Inc

About The Position

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. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do. Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. 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, and 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. Our Clinical Operations Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Requirements

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

Responsibilities

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
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
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
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
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
Attends clinical training sessions according to the project-specific requirements
May support training and mentoring of Associate QRM
Supports internal and sponsor audits and participates in efforts to ensure readiness
Identifies opportunities for process improvements and communicates to RBQM leadership