- Thermo Fisher Scientific
116 E Main St
When you re part of the team at Thermo Fisher Scientific, you ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you ll be supported in achieving your career goals. What will you do? Responsible for understanding the core clinical trial study requirements, including relevant details which will shape ongoing study decisions. Ensures a basic understanding of the therapy associated with the clinical trial. Responsible for review project plan(s) with associated documents to ensure firm understanding of study and timelines. Anticipates changes to existing project plans as needed following internal processes (e.g. quoting). Ensures changes are communicated promptly to all cross functional / resources to ensure all phases of execution align with the plan. Can also create project plan for simple projects. Acts as single point of contact for client and coordinates key activities with other FCS functions as required. Responsible to review and understand the demand and supply plan. Executes work according to the plans. Must be able to modify plans for existing studies as needed. Creates new demand / supply plans for simple studies using approved tools and processes. Responsible to set up and modify simple jobs in the project management system (GPM). Information includes, Purchase requisitions, IL Information/export information. Other items include ensuring all distribution information is communicated to all depots, for example quotes are sent, country of manufacturing, pricing etc. All studies should be set up in a timely manner so there is no patient impact. Responsible for Kick off meeting with Sales as well as Kick off meeting with Client. Leads weekly study meetings on a regular basis providing study status, and recommendations to address emerging study issues. Send agendas in advance, takes meeting notes for documentation and communicates deliverables to clients. Meetings are filed in Sharepoint. Responsible to communicate regularly with client providing updates on key issues. Negotiates effectively with clients regarding study plan without damaging relationships. If there are questions regarding what a client needs or wants and it is not a current standard of service it is to be brought directly to the attention of management. Ensure project scope is maintained without scope creep, change orders must be completed if additional services or ancillaries are required. Unfavorable news must be delivered in a timely manner with a possible resolution; if the issue is major it needs to be escalated with everything documented Accountable for all procurement to meet planned study timelines Overall responsibility to ensure all ancillaries get to the depots in a timely manner by being the Single Point of Contact for all depots and Export. Responsible to understand import/export requirements for global distribution of materials for studies. Clarifies questions with Export teams, prepares appropriate documentation in advance, and coordinates with distribution teams. Ensure the quantities of ancillaries to each depot is known and given to the ASCC prior to shipments to the depot. Responsible to create inventory management plan for all studies including re-order point (ROP) and reorder quantities (ROQ) for each item and distribution location. This information needs to be given to the ASCC and updated as needed. This is to ensure no stock-outs occur at any distribution location. Adjust inventory management plan as needed based on enrollment and other study changes. Responsible to create and modify manual order forms or the use of Global Gateway Web Order Entry. Ensure all Depot specific forms are accurate and effective approving all revisions prior to client use. Resolve all shipment issues as needed. Ensure all site shipments are accurate and on-time. Ensure appropriate part numbers are on the right manual order forms and there is no unblinded users in Global Gateway. Responsible to review and approve inventory and distribution reports templates prior to use. Ensure report templates are accurate, accessible, unblinding and consistent with client quote. Requests cope changes through approved quoting and approval processes prior to approving custom reports or additional reports to client. Establish automated reporting where applicable through SQL server or Global Gateway. Responsible to modify Returns Management plan for standard studies and create management plan for simple studies. Accountable to manage successful execution of all return activities including returns, reconciliation and destruction. Ensure all activities are in compliance with approved SOP's and signed quotes. Responsible to modify study close-out guidelines for standard and simple studies. Ensures close-out activities are completed on time as outlined in the client quote. Responsible for successful execution and accuracy administrative duties needed; including billing packets, financial forecasts, internal reports, metrics, etc. Ensures accuracy of billing packets for assigned projects. Accountable to bill for all activity in the month it was performed. Supports special projects as required. (WI's) Understands and complies with client-specific Quality / Technical Agreement (QTA) for assigned studies. Alerts clients to quality issues as required. Manages quality events in compliance with approved policies. Supports trackwise investigations as needed. Responsible to run queries, analyze and interpret data, manipulate reports, and run pivot tables using Excel, SQL and other tools. Requires intermediate skills level for spreadsheets.
Minimum Requirements: Minimum of 3 years of project management and clinical supplies, healthcare, or medical device Ability to work as part of a cross-functional team for study management activities Exemplary computer skills, including high proficiency in Microsoft Suite including Excel, Word and MS Project as well as the Office 365 environment. Ability to analyze complex data and make informed decisions. Strong communication skills and attention to detail Strong organizational and self-management skills Experience working in GxP regulated environment, ISO, or other heavily regulated environment
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer.
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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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.* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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