Quality Risk Manager

Overview:

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. 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. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently hiring a Quality Risk Manager to join our team! The Quality Risk Manager (QRM) is key to driving successful project implementation of a Risk-Based Quality Management (RBQM) strategy. The Sr. QRM will work with the project team to lead and 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 Sr. QRM will provide mentoring, training and oversight to junior level QRM staff. Additionally, the Sr. QRM will identify, revise, and implement changes to the overall RBQM process as needed.

The QRM 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! 

• Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.
• Facilitates and leads preliminary risk assessments and suggests appropriate anticipated study specific risks.
• Develops and maintains the Integrated Quality Risk Management Plan (IQRMP) in coordination with cross-functional team; updates IQRMP as needed
• Updates RBQM related procedural documents and templates, including the IQRMP template
• Provides review of RBQM strategy and process and implements updates as needed
• Provides training, mentoring, and oversight to new/junior QRMs
• Reviews study and site data listings and visualizations via analytical dashboards and/or reports to identify trends, risks, suspected scientific misconduct on other systematic errors that could impact data integrity and subject safety.
• Suggests updates to RBQM related procedural documents, templates, and overall strategy
• Immediately communicates/escalates serious issues to the relevant project team member(s) suggesting and developing action plans.
• Documents observations noted during reviews, investigates trends, issues and risks for root cause.
• Initiates set-up and provides inputs needed for KRI and QTL visualizations, via either a technology platform or an alternate tool.
• Maintains expert knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.
• For assigned activities, understands project scope, budgets, and timelines; manages study- and portfolio-level activities to ensure project objectives, deliverables and timelines are met.
• Must be able to quickly adapt to changing priorities to achieve goals/targets.
• May attend Investigator Meetings and/or sponsor kick-off meetings.
• Participates in project staff meetings as applicable and attends clinical training sessions according to the project specific requirements.
• Provides support of sponsor audits.
• Supports business development activities through bid defense meeting attendance and proposal development.
• Performs QTL reviews and is responsible for tracking Quality Tolerance Limits reviews, results and mitigations.
• Utilizes KRI dashboards, metrics and reporting systems and other analytical tools to synthesize data trends, issues, action items in a clear and concise presentation of the most relevant and actionable items for interpretation by Project Leads, Sponsors and other functional roles assigned follow-up.

• Bachelor's Degree preferred.
• At least 6 years of industry experience with developed therapeutic expertise.
• Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.
• Expert in Risk-Based Monitoring Strategies processes and tools preferred.
• Must demonstrate strong computer skills and be able to embrace new technologies, including mastery of Analytical Data Visualization Tools and techniques as well as MS Excel (sorting, filtering, calculating, pivoting).
• Strong analytical skills.
• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
• Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
• Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.
• Expected required travel 15% on average

A few more things to know about us:

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Diversity and Inclusion: As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day. By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

EOE. Veterans/Disabled

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