Project Quality & Risk Lead II

7 days left

Harrow, United Kingdom
23 Apr 2021
23 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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.

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