Clinical Ops: Device Lifecycle Specialist – Irvine (Onsite)

MillenniumSoft Inc; Irvine (CA); In loco; USD 73.000 - 83.000; Tempo pieno

Descrizione del lavoro

MillenniumSoft Inc in Irvine, CA is seeking a Clinical Operations Specialist 1 for onsite, 1st shift. The role supports device process development and clinical trial workflow optimization, managing the life cycle of trial devices and ensuring regulatory compliance.

Responsibilities include coordinating procurement, maintaining TMF documentation, forecasting inventory, and collaborating with cross-functional teams across Manufacturing Operations, Finance, Quality, and Compliance.

Competenze

• Must have 2+ years of clinical research experience or similar
• Onsite presence required, Monday–Friday, 8 AM–5 PM
• Experience with TMF or regulatory documentation is a plus

Mansioni

• Identify, develop, and implement process improvements to optimize trial workflows
• Develop and execute device processes for clinical trials ensuring regulatory compliance
• Coordinate procurement and shipments of study inventory to sites
• Maintain and file documentation in TMF and related systems
• Monitor inventory levels and support forecasting and planning
• Track study invoices and support payments and reporting

Conoscenze

Process development

Regulatory compliance

Cross-functional collaboration

Inventory forecasting

Documentation accuracy

Reporting skills

Formazione

Associate's or Bachelor's degree in related field

Descrizione del lavoro

MillenniumSoft Inc in Irvine, CA is seeking a Clinical Operations Specialist 1 for onsite, 1st shift. The role supports device process development and clinical trial workflow optimization, managing the life cycle of trial devices and ensuring regulatory compliance.

Responsibilities include coordinating procurement, maintaining TMF documentation, forecasting inventory, and collaborating with cross-functional teams across Manufacturing Operations, Finance, Quality, and Compliance.