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Company

Rho · 7 hours ago

Quality Risk Manager I or II

United States

Full-time

Remote

Mid Level

$60K/yr - $85K/yr

3+ years exp

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Responsibilities

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.

Qualification

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Risk-Based Quality ManagementClinical PracticeAnalytical Data Visualization ToolsRegulatory ComplianceData AnalysisProject ManagementMicrosoft ExcelMentoring

Required

Bachelor's Degree preferred.

At least 3 years of industry experience with developed therapeutic expertise.

Expert in Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.

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.

Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience.

Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment.

Expected required travel 15% on average.