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* Collaborate with business users to consolidate and document requirements for DH capabilities.
* Support planning and execution of validation and qualification processes for supplier systems.
* Write and execute detailed test scripts with precision and accuracy.
* Review and contribute to System Development Lifecycle (SDLC) documentation, including supplier release notes and change memos.
* Engage with stakeholders across privacy, security, quality, and regulatory functions.
* Participate in audits and inspections, fulfilling documentation and data requests.
* Support data standardization, integration, and ingestion across the DH landscape.
* Oversee supplier systems, managing issues, risks, and escalations as needed.
* Ensure compliance with internal processes and external regulatory requirements.
Key Responsibilities
* Collaborate with business users to consolidate and document requirements for DH capabilities.
* Support planning and execution of validation and qualification processes for supplier systems.
* Write and execute detailed test scripts with precision and accuracy.
* Review and contribute to System Development Lifecycle (SDLC) documentation, including supplier release notes and change memos.
* Engage with stakeholders across privacy, security, quality, and regulatory functions.
* Participate in audits and inspections, fulfilling documentation and data requests.
* Support data standardization, integration, and ingestion across the DH landscape.
* Oversee supplier systems, managing issues, risks, and escalations as needed.
* Ensure compliance with internal processes and external regulatory requirements.
Required Qualifications
* Previous experience working in the CRO, Healthcare or Pharmaceutical Industry
* Experience in Computer System Validation (CSV) and audit/inspection participation .
* Familiarity with Software Development Life Cycle (SDLC) and GAMP5 methodology .
* Strong understanding of Clinical Trial SaaS platforms/applications .
* Excellent documentation, analytical thinking, and problem-solving skills.
* Ability to manage and communicate with multiple stakeholders effectively.
* Detail-oriented with a strong focus on process and activity execution.
Preferred Experience
* Knowledge of systems used by preferred or established suppliers in the clinical trial space.
* Experience supporting system integrations and change control processes.
* Exposure to data governance and digital health data ecosystems .
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
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Seniority level
* Seniority level
Entry level
Employment type
* Employment type
Full-time
Job function
* Job function
Management and Manufacturing
* Industries
Hospitals and Health Care
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