ICON Strategic Solutions · 2 days ago
Senior Auditor, Vendor Quality Assurance (Imaging)
United States
Full-time
Remote
Senior Level
Maximize your interview chancesPharmaceuticals
Hiring Manager
John Burgess
Insider Connection @ICON Strategic Solutions
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Responsibilities
Monitoring the collection, processing, and analysis of data for sponsored clinical trials
Monitoring and evaluating Supplier compliance and data quality
Tracking corrective actions in relation to monitoring issues and audit findings; escalates as appropriate
Developing professional relationships with with sponsor stakeholders
Support the planning, management and execution of Supplier Performance Management Services related monitoring activities
Support Global Development Operations, Global Study Management, and therapeutic area teams by monitoring to ensure the quality and integrity of processes and data generated by external Vendor/Service Suppliers
Gather business requirements to develop Pre-Visit letters and design and generate reports in support of supplier monitoring activities (eg, Clin Ops DB, IMS)
Plan and conduct monitoring visits as delineated in the annual monitoring plan
Assist in 'in-house monitoring' or 'remote monitoring' activities as delegated by management or business need
Ensure the quality and integrity of processes and data generated by Suppliers for sponsor clinical trials
Assist in the distribution and archival of key outputs from Supplier Performance Management Monitoring. (e.g. Monitoring Visit Reports)
Qualification
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Required
Previous experience managing imaging vendors is required.
Monitoring the collection, processing, and analysis of data for sponsored clinical trials.
Monitoring and evaluating Supplier compliance and data quality.
Tracking corrective actions in relation to monitoring issues and audit findings; escalates as appropriate.
Developing professional relationships with sponsor stakeholders.
Support the planning, management and execution of Supplier Performance Management Services related monitoring activities.
Support Global Development Operations, Global Study Management, and therapeutic area teams by monitoring to ensure the quality and integrity of processes and data generated by external Vendor/Service Suppliers.
Gather business requirements to develop Pre-Visit letters and design and generate reports in support of supplier monitoring activities (eg, Clin Ops DB, IMS).
Plan and conduct monitoring visits as delineated in the annual monitoring plan.
Assist in 'in-house monitoring' or 'remote monitoring' activities as delegated by management or business need.
Ensure the quality and integrity of processes and data generated by Suppliers for sponsor clinical trials.
Assist in the distribution and archival of key outputs from Supplier Performance Management Monitoring (e.g. Monitoring Visit Reports).
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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