Clinical Data Standards Expert – Non-Interventional Studies (NIS) (m/w/d)

We are seeking a highly skilled Clinical Data Management (CDM) Standards Expert with a strong background in Non-Interventional Studies (NIS) and Metadata Repository (MDR) systems and standards . This role is ideal for a candidate with a project management mindset who can independently lead initiatives focused on data standards governance and provide expert CDM support to the NIS team.

Key Responsibilities:

• Lead and manage projects related to clinical data standards governance .
• Act as the primary CDM liaison for the NIS team , ensuring alignment with study requirements and regulatory expectations.
• Drive strategic and operational discussions with MDR vendors to ensure effective collaboration and delivery.
• Support the implementation and maintenance of MDR systems , ensuring consistency and compliance with internal and external standards.
• Provide expert guidance on CDM processes and best practices in the context of NIS.
• Collaborate cross-functionally with internal stakeholders to ensure data quality and integrity across studies.

Required Qualifications:

• Minimum of 10+ years of experience in Non-Interventional Studies , MDR systems and data standards (e.g., CDISC, SDTM).
• Demonstrated ability to independently manage projects and drive cross-functional initiatives.
• Experience working with external vendors
• Excellent communication, organizational, and stakeholder management skills.
• Ability to work in a fast-paced, dynamic environment with minimal supervision.
• Drove MDR compliance by collaborating with MDR vendors on system requirements, data mapping, source documentation review, and ensuring audit readiness.
• Delivered MDR-compliant database solutions for post-market studies with zero critical findings.
• Independently led multiple NIS studies , focusing on Real-World Evidence (RWE) and post-market surveillance in alignment with EU MDR standards.
• Created operational SOPs and templates for data standardization in NIS trials.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com