RHO

Senior Quality Risk Manager

Job Location US-NC-Durham
ID
2021-1739
Type
Regular Full-Time

Overview

The Sr. 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.

 

 

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.

Qualifications

  • At least 6 years of industry experience
  • 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.
  • Mastery of MS Excel (sorting, filtering, calculating, pivoting).
  • Mastery of Analytical Data Visualization Tools and techniques preferred
  • Strong analytical skills.
  • Developed therapeutic expertise.
  • Excellent verbal and written communication skills.
  • Excellent presentation skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
  • Strong time management, technical and organizational skills.
  • Demonstrated ability to delegate tasks as appropriate
  • Expected required travel 15% on average

  EOE. Veterans/Disabled

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