Senior IT Auditor, Clinical Research
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Job Location:
Monthly Salary:
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description Summary Senior IT Auditor
Location: Bengaluru (Hybrid) Global travel up to 2040% depending on study/vendor portfolio
Job Overview
Plan and conduct independent technology audits to assess compliance with regulations guidelines and operating procedures.
Prepare and distribute reports of findings to supervisor operations staff management and customers.
Provide consultation in interpretation of regulations guidelines policies and procedures.
Support management in promotion and assessment of compliance to regulations guidelines and corporate policies.
Essential Functions
Plan schedule conduct report and close audit activities across countries to assess compliance with regulations customer requirements SOPs and project guidelines.
Audit Planning & Strategy
Perform risk assessments on technology vendors; determine audit type scope and cadence.
Audit Execution
Lead qualification for-cause and surveillance audits of vendors delivering eClinical solutions medical information systems data hosting/analytics AI/ML tools DCT components and GxP-relevant cloud services.
Evaluate audit findings and prepare reports.
Provide interpretation on regulations guidelines compliance status policies and procedures.
Consult customers and monitors on audit observations and CAPA plans.
Manage Quality Issues as required.
Deliver training and guidance on compliance procedures.
Review and approve investigations RCA CAPA and EC plans; track quality events to closure.
Evaluate policies for compliance and recommend process improvements.
Host audits/inspections and support regulatory inspection readiness.
Maintain eQMS updates and support audit lifecycle activities.
Lead/support QA improvement initiatives and train new QA staff.
Qualifications
Bachelors degree in Life Sciences Computer Science Information Systems.
10 years of experience in pharmaceutical technical or related GxP QA/CSV/IT audit roles.
Strong knowledge of R&D processes regulatory environments and SaaS/eClinical vendor auditing.
Ability to work independently and lead onsite/remote audits internationally.
Strong interpersonal problem solving risk analysis negotiation training and communication skills.
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
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
Senior IC
Key Skills
- IT Experience
- Risk Management
- COSO
- IT Auditing
- PCI
- COBIT
- NIST Standards
- SOX
- Information Security
- ISO 27000
- Internal Audits
- FISMA
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
