Currently working as a Sr Clinical Supplies Project Manager at PRA, a contractor for Merck & Co. In my current position, I work closely with the trail manager to complete all activities required for clinical study start up. Some of my high level responsibilities are to forecast drug inventory for upcoming clinical trials by having new drug
Currently working as a Sr Clinical Supplies Project Manager at PRA, a contractor for Merck & Co. In my current position, I work closely with the trail manager to complete all activities required for clinical study start up. Some of my high level responsibilities are to forecast drug inventory for upcoming clinical trials by having new drug product created, packaged and ready for distribution. Also to manage drug supply inventory at site and on hand, plan upcoming transfers, and complete end to end shipments.
-Highly experienced in Enterprise Resource Planning (ERP; JDE), Citrix, POMs, SAP and Cognos software.
-Possess a natural ability to build strong relationships
-Equally comfortable performing as a team leader or team member.
-Highly focused on the quality and attention to detail.
-Extremely hardworking and possess time management skills needed to complete tasks.
-Proficient in Microsoft Office: Access, Excel, PowerPoint, Word, and search engines
Sr. Clinical Supplies Project Manager (Protocol Level Planning) @ -Create/ Maintain finished good (FG) forecast for all studies for initial release
-Create/ Maintain FG Item Masters
-Create/ Maintain Address Books
-Maintain/revise of FG forecast for the life of study (LOS)
-resupply, new countries, RED label generation
-Work with comparator products
-Create/ maintain Clinical Supplies Specification memos
-Create/ maintain Finished Good Product Tables
-Create/ maintain Supply Chain Tables
-Create/ maintain Packaging CSOPS (Clinical Supplies Order Processing System) for LOS
-Create field communication memos for site awareness of when drug is expiring
-Attend Supply planning meetings
-Assign bulk lot numbers and RED to Packaging Work Orders
-Initiate label translation request From March 2015 to Present (8 months) West Point, PAClinical Supplies Project Manager (Inventory Level Planning) @ -Create Drug Request Forms and Inter-Site transfer requests for new studies and resupplies
-Maintain spreadsheets to keep track of inventory that has been used, destroyed, or available
-Oversea projects from study preparation to final release for drug/supplies at site
-Monitor global clinical supply inventory for both IVRS and traditional studies
-Monitor re-evaluation/expiry dating for clinical study supplies and adjust drug distribution plan accordingly
-Resolve issues involving distribution of clinical supplies, including US & International shipments, temperature excursions
-Manage clinical supply complaints received from investigator sites and/or subsidiaries
-Interact with other departments to resolve any issues involving clinical supply inventory and distribution.
-Participate in weekly/monthly tactical meetings and process improvement projects/meeting. From August 2013 to March 2015 (1 year 8 months) West Point, PAClinical Supplies Project Manager- Systems @ -Fully support global clinical supplies data integration, migration, and file conversion activities
-Create UAT (User Acceptance Test) Script Author and Executor
-Works closely with UAT and Technical Application Leads on Business Scenarios
-Executes test scripts and conducts user acceptance tests
-Adhere to SDLC (System Development Lifecycle) and ensure corresponding supportive documentation is complete From August 2013 to May 2014 (10 months) West Point, PAClinical Supply Associate @ -Provide support for Clinical Demand Project Managers and Drug Supply Coordinators for Phase I, II, & III trials.
-Prepare and submit requests for shipment of drug supplies to clinical study sites or subsidiaries using JDE/ERP systems.
-Expert Coordinator and processor of Inter-Site Transfer Orders (STO), Clinical Supplies Order Processing System(CSOPS), Investigator Initiated Study Programs(IISP), and Systems Applications and Products(SAP)
-Tack the status of material in (POMS)
-Enter required event dates (CTMS IMPACT)
-Manage Acknowledgement of Receipt (AOR) forms received from clinical study sites
-Generate and maintain supply tracking sheets to monitor patient enrollment and shipments
-Work cross functionally, as needed, to address any issues involving the shipment of drug supplies
-Maintain and track all Clinical Complaints for department.
-Mentor new CSA's From October 2011 to August 2013 (1 year 11 months) Blue Bell, PACatering Supervisor @ -Supervise 10+ employees
-ensure that events run smoothly
-help with setup and breakdown of events
-assist quest and make sure all their needs are met From October 2010 to November 2011 (1 year 2 months) Manager @ -Managed the facility and staff
-Performed opening and closing duties
-Filed documents and uploaded important business data
-Provided customer support From May 2011 to August 2011 (4 months) Seaside Heights, NJIntern @ -Developed sales leads for ADP Senior District Managers within their respective territories
-Assisted Senior District Managers build reciprocal relationships with existing client base
-Created educational presentations as well as motivational materials From February 2011 to May 2011 (4 months) Fort Washington, PA
Bachelor of Science in Business Administration, Major: Business Management with a concentration in Marketing @ Widener University From 2007 to 2011 Nicholas Dughi is skilled in: Leadership, Management, Time Management, Customer Service, Access, PowerPoint, Microsoft Word, Microsoft Office, Microsoft Excel, Sales, Marketing, Social Media, Social Networking, Account Management, Event Management
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