US Clinical Operations Consultant (SE S00207)

We’re running a paid, freelance consulting project to support a client exploring market entry for an at-home diagnostic product. The client is seeking expert input to better understand the operational landscape, including kit logistics, sample return, and regulatory compliance.

We’re looking for an experienced Clinical Supply Chain / Operations Consultant to provide insight and strategic guidance on building a scalable, patient-friendly logistics system.

🔍 What you’ll help with:

• Advising on end-to-end supply chain design for at-home sample kits
• Optimizing kit packaging for safety, compliance, and cost
• Defining reverse logistics strategies and sample tracking systems
• Recommending vendors, SOPs, and operational infrastructure
• Ensuring compliance with FDA, CLIA, and biological material shipping standards

✅ Requirements – Supply Chain / Operations Consultant (Freelance Clinical Logistics Focus)

Must-have qualifications:

• 5+ years of experience in supply chain or operations roles within healthcare, diagnostics, or medtech — ideally involving patient-facing products
• Proven track record with at-home sample collection logistics, including reverse logistics and lab integration
• Familiarity with clinical diagnostic workflows — including sample stability, chain-of-custody, and transit time requirements
• Knowledge of CLIA lab operations and U.S. regulatory frameworks (e.g., LDTs, FDA, shipping of biological specimens)
• Experience optimizing packaging design and transport for clinical specimens, including environmental validation (temperature, humidity)
• Ability to advise on standard operating procedures (SOPs) for sample handling, inventory, and vendor management
• Strong understanding of direct-to-consumer (DTC) models in regulated healthcare settings
• Excellent communication skills; ability to clearly explain operational and clinical trade-offs to cross-functional teams
• Comfortable with freelance, short-term consulting engagements, with flexible availability based on client needs

Preferred qualifications:

• Experience in oncology diagnostics or other regulated screening programs
• Background in scaling logistics for diagnostic tests intended for high-volume use (e.g., >100K samples/year)
• Familiarity with validation requirements for sample shipping (e.g., dry ice, time/temperature sensitivity)
• Prior involvement in early-stage commercialization or market entry planning for clinical products

✅ You bring:

• Experience in healthcare supply chain operations — especially at-home diagnostic kits
• Familiarity with direct-to-consumer distribution models and reverse logistics
• Knowledge of U.S. regulatory frameworks for LDTs and IVDs
• Background in cancer diagnostics or lab workflows is a plus

💼 Project Details:

• 💸 Paid freelance engagement
• 🧠 Interview/discovery phase — help the client better understand market needs
• 🕒 Part-time / hours based on client scheduling
• 🌍 Remote