Manager, Clinical Supplies and Logistics – Ascent Services Group – San Diego, CA, USA
The Clinical Supplies Manager (CSM) will support the Clinical Supplies team’s activities related to Clinical Trial Material (Phase 1-4); cooperate with internal and external customers and partners in compliance with multinational regulations as well as internal procedures and GxP requirements.
- Responsible for supporting and/or managing complex studies requiring Clinical Supplies project management, forecasting, IXRS, distribution, and supply logistics such as packaging/labeling and global distribution.
- This position will interface with Clinical, Project Management, Regulatory, QA, Diagnostics, Manufacturing and Quality Control teams.
- The CSM will manage vendors involved in the planning, distribution, storage and destruction of Clinical trial supplies for Clinical investigational sites as required.
- Prepare Clinical Trials Materials (CTM) supply forecasts based on projected needs of clinical trial study protocols
- Coordinate supply of CTM, based on study and drug forecasts, with Clinical, Manufacturing and Medical project managers, as well as contract distribution partners
- Manage CTM, both internally and with distribution partners, including packaging, labeling, and global distribution of clinical supplies
- Work collaboratively with other departments for the creation and approval of product labeling. Manage labeling and packaging operations with vendors. May negotiate supply/technical agreements, and act as primary liaison between the company personnel and contractor(s) on assigned projects
- Support the development, implementation, and maintenance of IXRS systems
- Process manual orders for CTM to be shipped by from contractors for all studies operating outside of IXRS automated supply systems
- Maintain clinical supplies inventory for assigned projects by interfacing with vendor to ensure that inventory systems are kept up-to-date and that final product reconciliation is accurate
- Develop Standard Operating Procedures (SOPs) related to inventory management, distribution, transportation, and disposition of returned/unused materials. Develop SOPs and tools to support outsourcing oversight
- Ensure that key supply project milestones are met while maintaining open communication on supply plan timelines with internal and external customers and partners
- Select and manage vendors for the supply of centralized services such as clinical trial supplies distribution, specialty labs, central medical test suppliers
- Oversee vendors from start-up to close-out, including budget negotiation process, and ensure study budgets are managed to plan and scope
- Coordinate the provision of clinical lab kits to sites and tracking of samples back to labs, delivery of clinical test results and sample storage/destruction as required by protocol
- Ensure consistency of processes and documentation across multiple studies
- Lead efforts in designing and implementing off-site inventory storage for disaster recovery
- Work with QA and Lab Administration to maintain on-site IMP storage equipment in validated state
- Track and manage temperature data associated with shipments of clinical drug supplies
- Ensure that all documentation of product and test article accountability is present in trial master file and submission-ready
- Coordinate and lead regular clinical supplies logistics meetings with cross-functional teams to ensure accurate, open, and timely communication on supply and logistics issues across all applicable functional areas
- Performs other clinical supplies, logistics as well as data base management duties as required for Clinical and CMC Departments.
- Performs other duties as required.
- Bachelor’s degree in a relevant field and at least 5 years Clinical Operations experience including experience with import, export and IATA regulations, as well as supply and cold chain management.
- Strong understanding of CFR and ICH guidelines, regulations and guidelines governing conduct of clinical studies.
- Well-organized and detail-oriented with strong technical skills, solid written and verbal communication skills, and proven ability to multitask
- Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team and manage multiple vendors
- Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines
- Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves in order to thrive in small company environment
- Demonstrated ability to effectively negotiate contracts and financial terms
- Ability to appropriately manage and maintain blinded study information