Job Summary: 

• Serve as a subject matter expert on the Clinical Supply Chain Optimization Services (CSOS)
• Provide business development support to the commercial team in meetings with existing and potential clients.
• Work with Fisher Clinical Services (FCS) sales to coordinate a full-service approach with prospective clients and represent and appropriately position the services for potential clients
• Interpret protocols to assess resource requirements for new client opportunities and finalize pricing for the quoting team
• Partner with both internal and external customers, employees, and the FCS sales force to develop solutions regarding clinical trial protocol interpretation
• Be responsible for study-level plans that enable planned enrollment
• Project management, forecasting, developing labeling strategies, packaging plans, drug product requirements planning, distribution network planning, data management, temperature excursion management
• Plan for study drug returns and reconciliation.
• Manages resource management process and project staffing of the CSOS team
• Attends relevant client-related meetings and appropriately represents the status of the Clinical Supply Chain
• Develops standards for employee and department performance in partnership with the Director of Clinical Supply Chain Optimization
• Provides direct management, mentoring and ongoing coaching and development support for a team of Clinical Supply Chain Managers (CSCMs) and Drug Supply Coordinators (DSCs) 
• Engages and participates in divisional initiatives that are related to or involve Clinical Supply Optimization

Skills on Resume:

• Supply Chain Expertise (Hard Skills)
• Business Development (Soft Skills)
• Client Coordination (Soft Skills)
• Protocol Interpretation (Hard Skills)
• Solution Development (Soft Skills)
• Project Management (Hard Skills)
• Resource Management (Hard Skills)
• Team Leadership (Soft Skills)

Job Summary: 

• Logistics reporting with the internal and external partners.
• Assist in compliance with customs and trade requirements for global shipments.
• Planning of CTM/IMP for all clinical trials, deriving an execution forecast
• Maintain oversight of supply and shipments
• Generate reports/metrics to ensure supply needs are being met to support clinical operations.
• Compile and route Label Copy Approval Forms, Shipping Authorization Forms, etc. to maintain business continuity centered around clinical operations.
• Maintain shipment database, including Trial Master File (TMF), for required documents in accordance with regulations.
• Support clinical packaging/labeling processes.
• Compile weekly dashboards and slides centered around CMC-related operations supporting clinical supply activities
• Maintain inventory oversight and support the forecasting and budget processes
• Select and establish INCO terms, FDA product codes and HTS codes.
• Develop shipping forecast with Clinical/Commercial Operations.
• Ensure batch release dates are supportive of the shipment schedule.

Skills on Resume:

• Logistics Reporting (Hard Skills)
• Customs Compliance (Hard Skills)
• Forecasting Execution (Hard Skills)
• Supply Oversight (Hard Skills)
• Regulatory Documentation (Hard Skills)
• Clinical Packaging Support (Hard Skills)
• Inventory Management (Hard Skills)
• Shipping Coordination (Hard Skills)

Job Summary: 

• Assign and prioritize release dates for manufacturing, packaging and labeling timelines, based on need and input from Manufacturing, Regulatory and Quality.
• Create shipment documents, e.g. Proforma invoices, End Use Letters, USDA Letters, import applications and permits.
• Maintain shipment database for the required documents for international shipments.
• Establish clear communication and tracking of strategies and scenarios for Project Teams and senior management.
• Lead necessary vendor selection process, obtaining RFPs, establishing competitive bids and negotiation of agreements.
• Onboard and manage relationships with contract organizations, including establishing agreements, quotes, purchase orders and invoicing.
• Assist Finance with inventory reconciliation and financial close.
• Establish consistency of commercial & clinical supply strategy across product lines 
• Compliance with Ultragenyx policies, procedures and applicable regulatory authority directives and regulations.
• Support Supply Chain Specialist's shipments, including importation/exportation compliance of labeled supply 
• Appropriate drug depot and subsequent shipment to the clinical sites.
• Track all shipment issues (damage, temperature excursions, non-compliance, etc.) and work to resolve recurring problems with permanent solutions. 
• Work within the Ultragenyx Quality systems to drive closure of deviations and/or change controls

Skills on Resume:

• Timeline Coordination (Hard Skills)
• Document Management (Hard Skills)
• Database Maintenance (Hard Skills)
• Communication Strategies (Soft Skills)
• Vendor Negotiation (Hard Skills)
• Relationship Management (Soft Skills)
• Financial Reconciliation (Hard Skills)
• Problem Resolution (Soft Skills)

Job Summary: 

• Plan, designed and executed packaging and labeling campaigns: Balance finished goods supply and demand through Rapid Response, exception management, and Systems Applications and Products
• Translate clinical protocol information into demand forecasts and supply strategies
• Develop IRT supply specifications and clinical label texts
• Manage CMOs to deliver study material on time and within budget
• Manage IP distribution through study closeout and drug destruction
• Lead process improvement initiatives and author\revise clinical supply SOPs
• Enable successful clinical trials using supply chain management processes (Plan, Source, Make, Deliver, and Return)
• Potentially program management, which includes maintaining program timelines, dashboards, and other internal documents.
• Manage relationships with packaging and labeling CMOs and track vendor performance.
• Managing Contracts, Expenses and Invoices
• Provide input to production plans based on inventory projections

Skills on Resume:

• Supply Planning (Hard Skills)
• Demand Forecasting (Hard Skills)
• IRT Management (Hard Skills)
• CMO Oversight (Hard Skills)
• Process Improvement (Soft Skills)
• SOP Authoring (Hard Skills)
• Vendor Management (Soft Skills)
• Financial Oversight (Hard Skills)

Job Summary: 

• Review clinical study protocols and develop packaging/distribution strategies with the clinical operations team.
• Provide functional review of clinical study documents, e.g., IWRS specifications, pharmacy manuals, etc.
• Create, review, and update clinical supply packaging plans to meet the demands of multiple clinical trials
• Set packaging and labeling schedules
• Supervise on-time completion at Contract Manufacturing Organizations (CMOs)
• Work closely with Quality Assurance, Regulatory Affairs and Clinical Operation teams for production input into the supply chain, development of label specification
• Ensure the release of products domestically and internationally
• Plan, schedule, and manage inventory and logistics of clinical studies (secondary packaging and labeling activities)
• Manage Finished Goods shipments between international and domestic depots and clinical sites
• Review and resolve all shipment issues (e.g., damage, temperature excursions, non-compliance)
• Partner with Clinical Operation and Contract Research Organizations (CROs) on site-level documentation and processes governing supply

Skills on Resume:

• Protocol Analysis (Hard Skills)
• Documentation Compliance (Hard Skills)
• Supply Chain Management (Hard Skills)
• Logistics Scheduling (Hard Skills)
• Quality Assurance (Hard Skills)
• Team Collaboration (Soft Skills)
• Problem Solving (Soft Skills)
• Stakeholder Management (Soft Skills)

Job Summary: 

• Producing trial documentation for the Trial Master File.
• Maintaining and updating trial documentation, including trial specific procedures and case report forms (CRF).
• Ensuring all current regulatory requirements are met and approvals are obtained.
• Ensuring biological samples are sent to central laboratories.
• Maintaining site files and patient records held at the CECM.
• Providing information to sites on IMP support and management as applicable and reviewing compliance.
• Preparing and maintaining a trial risk assessment.
• Performing central monitoring according to the monitoring plan.
• Maintain awareness of product expiration dates and supply levels to meet the needs of multiple sites, trials, and patients
• Oversee inventory levels at the clinical sites and CMOs
• Identifies improvement opportunities for the CSOS team

Skills on Resume:

• Documentation Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Sample Logistics Coordination (Hard Skills)
• Risk Assessment Preparation (Hard Skills)
• Central Monitoring Execution (Hard Skills)
• Inventory Management (Hard Skills)
• Communication and Information Dissemination (Soft Skills)
• Process Improvement Identification (Soft Skills)

Job Summary: 

• Ensures project-specific data is configured and maintained in the appropriate Fisher Clinical Services proprietary systems.
• Takes the lead in developing solutions to solve issues with existing clients and projects
• Leverages understanding of Fisher resources to propose solutions to clients
• Identifies. recommends, and leads process improvement initiatives
• Supports communication of best practice through shared learning sessions, contribution to guidelines and SOPs
• Identifies new CAM and other service line opportunities with existing clients and engages Business Development resources accordingly
• Establishes and maintains financial forecasts and monthly billing processes for assigned client projects
• Recognizes contracted scope of services and connects with the appropriate resources for extensions of service
• Verifies final project management, procurement, storage and distribution information for the Finance Department prior to invoices being released Develops and administers training on CAM business processes
• Assists in training and onboarding of new employees
• Participates in sales and marketing activities such as teleconferences, customer visits, audits, estimates and proposals with Sales and other Clinical Ancillary Management personnel.
• Maintains accurate records and files in accordance with Clinical Ancillary Management Policies & Standard Operating Procedures (SOPs). 

Skills on Resume:

• Data Configuration and Management (Hard Skills)
• Solution Development (Soft Skills)
• Resource Utilization (Soft Skills)
• Process Improvement Leadership (Soft Skills)
• Best Practice Communication (Soft Skills)
• Opportunity Identification (Soft Skills)
• Financial Forecasting and Billing (Hard Skills)
• Training and Onboarding (Soft Skills)