Responsibilities:
· Designs and implements strategic plans to supply study drug to complex global clinical trials using sound supply chain techniques
· Devises and implements inventory management plans that have complex supply chains
· Reviews, interprets and implements supply forecast plans from internal or external source documents and tools.
· Provides input into user requirement specifications of Interactive Response Technology (IRT) medication management module(s) as needed.
· Reviews IRT strategy to ensure it supports the strategic supply plans and ensures that IRT settings are adjusted to optimize the supply chain
· Executes IRT User Acceptance Testing, if required
· Leverages the inventory management capabilities of the IRT to appropriately manage studies
· Executes supply chain inventory management processes in partnership with internal Clinical Supply Optimization Services team members and packaging partners.
· Serves as the global project lead on assigned projects, ensuring internal project resources are focused on delivery and client satisfaction, leading by example and negotiating across geographic and functional lines
· Plans and manages execution of initial supplies and resupplies for assigned studies
· Ensures temperature excursion process is executed as required
· Proactively identifies potential supply chain issues, provides analysis and recommends solutions
· Performs study close out activities including returned good reconciliation, inventory destruction processing, and file archiving
· Summarizes data, prepares presentations and makes recommendations for action relative to the clinical supply chain and packaging plans
· Develops and provides client(s) with reports on actual project spend versus budget
· Negotiates effectively with clients regarding study plan without damaging relationships
· Provides recommendations on packaging design, distribution and blinding strategy with existing clients
· Develops supply chain strategies for new clinical projects and initiates activities to support strategies agreed with clients
· Works with both internal and client Project teams to ensure consistent communication of clinical trial material supply status. Identifies potential risks, defines and executes risk mitigation plans.
· Takes 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 CSOS 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
· Develops and administers training on CSOS business processes
· Utilizes an extensive network in the pharmaceutical industry to generate and cultivate leads for the Clinical Supply Optimization Service (CSOS)
· Participates and presents at relevant industry conferences and seminars
· Works with Fisher Clinical Service sales and marketing to coordinate a full service approach with prospective clients, reviewing trends in customer requirements and proposing strategies
· Represents and appropriately positions the CSOS service for potential clients
· Utilizes understanding of Clinical Trial Supply Chain Management best practice principles to develop new or improve existing business processes and appropriately documents and revises or develops associated training materials
· Effectively mentors and coaches associates new to the Clinical Supply Optimization role on best practices associated with managing clinical supply chains
· Stays abreast of relevant cGMPs, GCPs, and other regulatory requirements and ensures study management activities are aligned
· Attend relevant client related meetings and appropriately represent status of the Clinical Supply Chain
· Demonstrates the ability to promote the company vision
· Conduct activities in a safe and efficient manner
· Other duties may be assigned to meet the needs of the business
Minimum Qualifications:
· Bachelors degree or higher in operations management or science-related field (equivalent work experience may be considered)
· Minimum of five (5) years clinical supply chain management experience
· Experienced in building and managing forecasts for clinical supply chains
· Excellent computer skills, including high proficiency with Microsoft Suite including Excel, Word and MS Project as well as the Office 365 environment.
· Strong Project Management Skills
· Significant travel (up to 50%) may be required, including international travel
· Ability to independently manage priorities and workday in a remote setting
Preferred Qualifications:
· Certificates: Certified Project Management Professional is preferred. APICS certification (CPIM) also desirable
· Exemplary communication and presentation skills, conceptual skills
· Excellent Teamwork and interpersonal skills
· Exemplary organization and self-management skills
· Ability to manage multiple tasks and respond to change
· Excellent oral and written communication skills
· Accuracy and attentiveness to details
· Demonstrated strength in leadership and coaching others
· Strong customer service experience
· Ability to identify problems and work toward a solution
· Demonstrated experience with multiple global clinical trials
