Senior Quality Lead, Real World Evidence en Madrid

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.

Senior Quality Lead, Real World Evidence

Central, Eastern and Southern Europe (CESE)

Homebased position

Flexible location in EU Region

We have an exciting opportunity for a Senior Quality Lead within Real World Evidence for the Central, Eastern and Southern Europe region (CESE) to play an instrumental role within our global business unit.  The role reports to Gyongyi Szedlay, Head of RWE, Global Operational Effectiveness

Role Purpose:

The Senior Quality Lead, will work across Data Generation, Project Management and Scientific Services to support a quality culture, consistent practices, ongoing process improvements, staff training, compliance, reporting, root cause analysis of issues, audits and proactive risk management.
 

Responsibilities are outlined below:

• Responsible for planning, coordination, control and continuous improvement of processes & methods established to control the quality of DG project delivery.
• Develop formal RWE Quality Excellence Plan, inclusive of implementation and maintenance of an operational excellence management system in alignment with the Project Delivery Matrix.
• RWE CAPA oversight
• RWE CAPA trending and analysis
• Continuous review of RWE SOP reading lists
• Create & lead a RWE Quality Governance Framework
• Assume ownership of all RWE SOPs – ensure reviews, DCRs, revisions are completed with relevant operational SMEs (document management & maintenance)
• Ensure process atlas remains current and in alignment with SOP, WI, Templates, Forms, Guidance, tools & process revisions
• Provide monthly/quarterly progress, findings & status to relevant stakeholders
• Serve as a main point of contact for quality-related questions. Be able to find root cause of problems, propose a solution and implement

About you:

To be successful in this role you will have a solid understanding of clinical and ideally real-world research and all the activities involved to effectively deliver observational studies and clinical trials.  You will also have some exposure to quality management in the pharma / clinical research setting.  You will have a drive to enhance quality standards with strong communication, influencing and delivery skills to achieve this.  

Next steps:

You will be contacted by one of our recruiters to arrange a prescreen call should your background be relevant for this opportunity who will be able to give you more information on this team and the opportunity and also explain the assessment process to you for this role.

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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.