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Project Quality & Risk Lead II

Employer
Parexel
Location
Harrow, United Kingdom
Salary
Competitive
Start date
23 Apr 2021
Closing date
23 May 2021

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Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Job Description

  • Analyze key risk indicators and investigate risk signals by performing, reporting and coordinating risk-based quality evaluations for assigned projects using dashboards, reports, metrics and other available tools.
  • Facilitate and drive the risk management process for assigned projects using the available tools.
  • Facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies.
  • Provide oversight, transparency and tracking of quality issues for assigned studies.
  • Assist with preparations, conduct and response/action plan development for audits/inspections as assigned.
  • Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter experts.
  • Partner with project teams to achieve and maintain inspection-ready state including story board oversight.
  • Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the roles of Portfolio/Client Quality Lead.
  • Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested.
  • Mentor new PQRLs as needed.
    • Qualifications

  • 3 years' + experience in clinical research or equivalent experience. Experience using root cause methodologies (5-whys, fishbone diagram, etc.) Knowledge of ICH-GCP principles, English proficiency (written and oral)
  • Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred.
  • Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
  • Analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.
  • Ability to develop professional, collaborative relationships both internally and with the client. Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues.
  • Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge.
  • Ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus.
  • Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables.
  • Ability to manage the complexity of a matrix environment while valuing the importance of teamwork.
  • Ability to travel, as required.
    • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

    Company

    parexel

    When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

    How to describe Parexel’s culture in one word: 

    Henry

     

     

    Working With Heart™ - Christina's perspective:

    Working With Heart™ - Christina's perspective:

     

    Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

    Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
     Uxbridge
    Middx
    UB8 1LZ
    United Kingdom
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