Senior Quality Specialist - Homebased or Office Based in Reading,UK (R1080132) in Reading, UK at IQVIA™

Date Posted: 8/23/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
    8/23/2019
  • Job ID:
    R1080132

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Join us on our exciting journey!   


IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.  
A career with IQVIA connects you to great opportunity to achieve professional success and impact healthcare around the world.  
This role is working in our Quality team, collaborating with UK Site Management, Clinical Lead, Project Leadership and QA teams.

With fantastic work/life balance and reduced travel,- only 2 site visits per month this is a great opportunity for an experienced CRA looking for career development.

The Senior Quality Specialist is responsible for providing support and assistance to Clinical Site Monitoring, Project Management and other Business Units to improve compliance with relevant ICH Good Clinical Practices (GCP), SOPs, applicable country regulatory requirements and guidelines.

Role details  
• Working in a Quality team of up to 25 people based in EMEA

 • Only 2 Site visits per month

• Home or Office Based

    Responsibilities

    • You will be supporting studies having quality issues

    • You will collaborate with UK SM, CL, PL and QA teams - excellent communication skills required.
    • Risk identification and assessment through data review and quality control processes either remote or on site
    • Provide support in risk mitigation, in planning corrective/preventive actions and guidance for improvement
    • Cooperate closely with the relevant Heads of business and other stakeholders and support maintaining focus on quality in project delivery.
    • Provide advice and support to operational teams within the assigned business line, including Clinical Research Associates, Line/Site Network Managers and other key stakeholders on all aspects of GCP compliance.
    • Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions, as applicable according to SOPs.
    • Inform Heads of Quality Management, Heads of the assigned business line of quality issues according to SOPs.
    • May provide assistance during audits and regulatory inspections to the operational teams
    • Act as the primary contact on clinical quality matters
    • Prepare periodic reports to the relevant stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.

    Requirements  
    • You should be life science degree educated with independent on-site monitoring experience.  • You've handled multiple protocols and sites across a variety of drug indications.  • Flexibility and ability to travel are paramount with strong communication, written and presentation skills.  
     

    If you feel you have the suitable attributes we encourage you to apply!

    Join Us

    Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

    Forge a career with greater purpose, make an impact, and never stop learning.



    Job ID: R1080132