Clinical Field Sales Specialist

Specialist 1, Clinical Operations responsible for developing and implementing process improvements to optimize global trial workflow timelines, managing device processes and lifecycle for clinical trials, and ensuring regulatory compliance. This is an onsite role, Monday-Friday, 8:00 AM-5:00 PM.

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• Identify, develop, recommend, and implement moderately complex process development and improvement solutions to optimize global trial workflow timelines (e.g., device return aging issues, open device issues/queries)
• Develop and execute device processes associated with clinical trials; ensure regulatory compliance and manage device lifecycle
• Partner with internal stakeholders (clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, Compliance) to lead device process execution and drive continuous improvement
• Coordinate procurement of study inventory and manage device shipment to clinical sites within established timelines
• Confirm receipt of study product at clinical sites; track product through final disposition; ensure required documentation is filed in the Trial Master File (TMF)
• Monitor internal device and study-specific inventory levels; support inventory forecasting and planning
• Develop timeline assessments in collaboration with clinical stakeholders to meet study milestones and deadlines
• Generate transparency reporting data and reports to support Sunshine Act compliance
• Track, manage, and coordinate clinical study invoice processing for timely review, approval, and payment; generate outstanding invoice reports for clinical study team review
• Ensure documentation is stored and archived appropriately within record retention facilities (e.g., Iron Mountain, ClinicalTrials.gov)
• Review and ensure accuracy/completeness of clinical study files; enter into computerized tracking system; file/scan for archive across multiple clinical research trials
• Support clinical research laboratory operations as needed
• Perform other incidental duties to support clinical study operations

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2+ years of clinical research experience (required)

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• Clinical trial device process management
• Process development and improvement
• Inventory forecasting and planning
• Cross-functional stakeholder collaboration
• Regulatory compliance (Sunshine Act, TMF documentation)
• Invoice processing and tracking
• Documentation management and archiving