Clinical Supply Chain Logistics Manager Contract

Title: Clinical Supply Chain Logistics Manager- Contract

Location: Remote, east coast preferred

Status: 12 month contract, Monday through Friday

Compensation: $55 to $60 an hour

 

Please note- This role requires experience in Clinical Supply Chain, candidates without this specific experience will not be considered at this time.

 

The Role:

We are seeking a Clinical Supply Chain Logistics Manager who will lead the shipping and distribution for all clinical supply and support departments for commercial and development materials. This position will manage both domestic and international shipments. Ensure trade compliance, conformance, and import/export controls are followed. The candidate will have a good understanding of cGMP and GDP regulations and remain current with best practices. Successful candidates will have to work closely with Clinical and Commercial Operations, Technical Operations, Quality Assurance, Regulatory Affairs; and multiple third-party CMOs, Depots and Customs Brokers.

Strong cross-functional team leadership and project management skills are essential requirements of the role. This role is the subject matter expert (SME) in distribution and logistics, including regulatory compliance, tax implications, and understanding commercial and developmental spending for shipments.

 

Day to Day:

• Work with our CMOs and distribution partners to ship products for clinical use
• Manage activities as an Importer of Records for clinical shipments
• Manage shipping qualifications for our Investigational Medicinal Products (IMP) products
• Attend CMO meetings and anticipate when shipments will be required for each program
• Help develop shipping lanes and coordinate with Import/Export Brokers to expedite and ensure timely delivery of products and goods throughout the network
• Understand IRT (Interactive Response Technology) systems to obtain and manage inventory and shipments of IMP
• Schedule transportation requirements, monitor movement, and intervene in exceptions
• Manage imports and exports in compliance with all applicable laws and regulations to ensure product moves quickly through customs to the consignee
• Resolve problems concerning transportation, imports/exports, and trade compliance
• Help optimize distribution strategy in terms of total costs and risks
• Work with distribution vendors and finance in the coordination of VAT-related activities
• Continuously enhance knowledge and experience in distribution, logistics, transportation, and import/export, including regulatory requirements, VAT tax, transit insurance, and customs
• Help coordinate primary and secondary packaging, labeling, distribution, return, and destruction activities with third-party vendors
• Work cross-functionally to help develop CTM label text, regulatory review, and translation activities
• Work with CMO to help facilitate QP release process
• Ensure IMPs are delivered to clinical investigation centers in a timely manner and without critical deviations
• Coordinate distribution, return and destruction of IMP activities with third-party vendors
• Perform proactive and continuous risk management of the end-to-end clinical supply chain (inventory management, shelf life, country approvals)

 

Qualifications:

• Degree in business or supply chain & logistics discipline with 3+ years of supply chain logistics and distribution management experience in a regulated environment.
• Direct experience overseeing commercial and/or clinical supply logistics is preferred.
• Candidate must have in-depth knowledge of domestic and international rules, regulations, benefits, and costs associated with all modes of transport for pharmaceuticals and chemicals along with extensive experience in Brexit, VAT Tax and Import/Export management for a virtual company.
• Proficiency with Microsoft PowerPoint, Excel and a general understanding of IRT systems and other inventory systems.
• Understanding of GMP and GCP preferred.