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2018-44885

2018-44885

Title 
Manager of Quality Oversight
Job Locations 
-
US-NC-Raleigh
US-Remote
US-PA-Blue Bell
Posted Date 
2/5/2018

More information about this job

Overview

PRA Health Sciences is a Clinical Research Organisation experiencing exceptional growth globally. The people we employ are key to this growth.

 

People don’t come to PRA to witness the future of clinical development, they come to shape it. With an average of more than 6 former employees returning to PRA each month we can confidently say that the grass is greener at PRA. Come join the movement and discover your passion, your purpose, your PRA.

 

For our Quality Assurance group in Europe we are currently recruiting a Manager of Quality Oversight to develop and implement client specific quality oversight programs.

 

You will be creating and delivering a comprehensive, global quality oversight plan in compliance with company SOPs (Standard Operating Procedures), GCP and clinical trials regulations. 

Responsibilities

The Manager of Quality Oversight: 

  • Provides expertise and guidance on global GCP topics, identifies compliance and quality trends and areas of potential compliance risk, proposes resolutions, oversees implementation of resolutions, and ensures effectiveness of solutions.
  • Collaborates with internal functional areas to help maintain PRA’s high quality standards of clinical trial development. 
  • Develop, implement and maintain quality oversight plans, tools and templates
  • May functionally manage 1- 5 colleagues within a matrix reporting structure
  • Leads the implementation of client specific quality oversight plans for assigned clients, projects and/or portfolios. 
  • Ensures the quality oversight plan is completed according to internal requirements and agreed upon client expectations 
  • Liaises with project team leads (e.g. PM, CTM, etc.) on identified quality issues, quality/compliance trends, and works within the team to address and mitigate identified risks.
  • Advises project team on global GCP regulations and guidance documents governing clinical trial development and serves as expert consultant to project teams and client representatives
  • Oversees the development and finalization of all audit finding responses.  Includes an assessment of completeness, compliance with GCP and PRA standards, and adequacy of response.
  • Facilitates personally and/or ensures facilitation of all project, client and/or portfolio related quality issues (e.g.CAPAs) and ensures effectiveness checks are instituted in a timely manner 
  • Develops and delivers training on lessons learned through Audits and Inspections 
  • Leads the evaluation and management of site specific escalations related to persistent or serious misconduct.
  • Participates, as requested, on quality related projects initiated by internal stakeholders
  • Provides reports on quality trends, observations and suggestions to Management
  • Liaises with the QA department in relation to inspection support requests and client audits, as appropriate
  • Performs risk assessments and root cause analyses as needed

Qualifications

To be successful in this position you should have

  • Minimum five years of clinical trial experience with GCP auditing
  • Experience leading cross functional teams 
  • Must have thorough understanding of ICH GCP, EU and US clinical trial regulations
  • Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies ad clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred
  • Read, write and speak fluent English AND Dutch; Fluency in other languages is a plus
  • An undergraduate degree or its international equivalent from an accredited institution required. Preferably in the health-sciences or computer sciences
  • Managerial experience in clinical research preferred
  • Knowledge of CRO / Healthcare / Pharmaceutical quality assurance activities preferred
  • Advanced degree preferred





PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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