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Job Description


· 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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