Lead unblinded communication and plan creation for 7 global clinical trials to ensure blind was maintained during decision making across blinded sponsor team.Forecasted clinical supply needs for domestic and global Phase I, II and III studies to ensure proper depot and site inventory with frequent resupply campaigns. Procured concomitant and comparator drugs for clinical trials as needed.Facilitated import and export documents required to transport clinical trial material (CTM) to its destination.Monitored and oversaw all packaging and labeling activities as well as ensured proper storage for all investigational products at depots and sites.Authored and reviewed label text and label design for investigational drugs used in clinical trials while maintaining proper regulatory and quality standards.Provided guidance for optimal investigational product packaging design and collaborated with CMC to manage investigational product packaging processes.Initiated and maintained budgets for CROs and vendors for clinical supply scope during lifetime of study.

Assumes team leadership responsibility in the management of end- to-end clinical supply chain logistics at the program level.Develops and assists in the selection of appropriate supply forecast models at program level.Coordinates the procurement activities for investigational product, comparator, and other NIMP and/or ancillary supplies at the program level.Interprets relevant protocol information to develop packaging/labeling design for high complexity studies.Supports design and set-up of IVRS system for high complexity studies.Coordinates the origination, proofing and transition of clinical study labels for high complexity studies.Manages drug supply delivery timelines with appropriate stakeholders.Prepares required documentation and facilitating activities for import and export of clinical supplies.Manages global supply inventory for medium to high complexity studies.Acts as primary point of contact in communication with all stakeholders to ensure clinical supply logistics are in place to meet program milestones.Monitors and manages retest dating for assigned study supplies.Resolves clinical supply complaints and addresses supply replacement requests, as required.Works closely with appropriate stakeholders to manage clinical supply forecasting and budget requirements at the program level.Serves as SME in managing clinical supply logistics.Trains and mentors junior clinical supply team members.Continually reviews processes and changes needed to improve alignment with customer needs.

Acts autonomously in the management of end-to-end clinical supply chain logistics for high complexity clinical studies.Develops and assists in the selection of appropriate supply forecast models for high complexity studies.Coordinates the procurement activities for investigational product, comparator, and other NIMP and /or ancillary supplies for high complexity studies.Interprets relevant protocol information to develop packaging/labeling design for high complexity studies,Supports design and set-up of IVRS system for high complexity studies.Coordinates the origination, proofing and transition of clinical study labels for high complexity studies.Manages drug supply delivery timelines with appropriate stakeholders.Prepares required documentation and facilitates activities for import and export of clinical supplies.Acts as primary point of contact in communication with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout duration of a trial.Monitors and manages retest dating for assigned study supplies.Resolves clinical supply complaints and addresses supply replacement requests, as required.Works closely with appropriate stakeholders to manage clinical supply forecasting and budget requirements for global studies.Trains and mentors junior clinical supply team members.Leads discussions or work streams to develop process efficiencies.

Responsible for providing overall global coordination of the entire clinical supplies lifecycle for the projects assigned.Provides consultation services to clients regarding global packaging, labeling, and distribution requirements.Serves as the main point of contact between the client, clinical project teams, third party vendors, and study sites.Manages clinical supply forecast, supply budget tracking and reporting.Handles coordination, maintenance, and tracking of drug shipments and returns

Act as primary specialist in the management of clinical supply logistics for clinical studies.Develop and manage supply forecast models for clinical studiesInterpret relevant protocol information to develop packaging/labeling design Support design and set-up of IVRS system Proactively communicate drug supply delivery timelines to appropriate stakeholdersTroubleshoot day-to-day supply issues at site level and above

• Assist the Supply Chain Managers to ensure the successful setup and management of the clinical supply chain • Monitor actual clinical inventory and compare values to the forecast • Consult on IRT requirements to ensure accurate supply management • Create and maintain customized supply chain management reports and Excel spreadsheets • Manage timelines and supply demand associated with Investigator Initiated Research •Lead trainings with new Supply Chain Coordinators to establish understanding and compliance of SOPs

• Manage and process user access requests for the IXRS systems• Provide Tier II support for IXRS inquiries• Lead client trainings for IXRS user access and highlight any potential concerns before study go-live• Mentor and train fellow Project Specialists to ensure compliance with company standards and quality checks

• Ensure incoming and outgoing calls are handled in accordance with company policies and triage technical support calls to other clinical services personnel appropriately• Trouble shoot technical support calls to solve problems encountered by users • Document technical support in accordance with ALMAC standards• Create new or improved training documentation for use by fellow Technical Support Representatives