Nicole (Lemley) Garrett Email & Phone Number

Morgantown, Wv, Us

United States

Forecast clinical supply demand and manage clinical supply inventory throughout the clinical trial globally. Adjust re-supply strategies by assessing clinical protocol revisions and analyzing enrollment rates, inventory usage, and trends. Utilize simulation tools and supply chain expertise to determine packaging campaign and distribution strategies. Work with IXRS vendors in creation of system specification for supply algorithms and manages drug supply portion of IXRS development for clinical trials. Manage clinical supply depot set-up and monitor depot inventory throughout study. Manage clinical drug for a wide range of study types, including packaging design and contingency planning. Build drug projections, distribution strategy, packaging schedules, as well as managing/monitoring depot and site inventory levels. Act as client advocate, assisting with study set-up with CRO. Work in an unblinded capacity with secure, confidential study information. Participate in and lead high level cross-functional teams. Manage the project budget (protocol and program level). Participate in CMC meeting to help manage expectations and ensure clear communication. Supports comparator procurement strategies. Requests manual drug orders as needed. Manage/monitor/procure ancillary and comparator supplies inventories. Provide final drug accountability reports to Clinical group. Coordinate drug return, accountability, and destruction process. Will manage IMP across multiple clinical trials when necessary.

Remote

• Regularly evaluate customer’s clinical trial supply portfolio and pipeline; lead strategic account review process with operational leaders to uncover organic and new growth opportunities• Recommend program enhancements to clients for their clinical trial supply plan based on an in-depth knowledge of broader offerings, industry trends, healthcare landscape/legislative impacts and the competitive environment• Direct forward-thinking discussions, challenge resolution and opportunity identification with pharmaceutical manufacturing partners that introduce new solutions/services to establish relationship as partner of choice for their clinical trial supply plans• Develop a deep understanding of customer’s clinical trial supply program goals and objectives. Lead cross-functional teams to develop mutual beneficial solutions and monitor performance, create an environment of constant customer contact and regular customer visits• Improve customer service quality results by analyzing, studying, evaluating, and re-designing processes; establish and recommend service metrics; monitor and analyze results; and recommend innovative solutions to create efficiencies within current operations for clinical trial supply plans• Participate in the contract renewal process when applicable and lead the contract negotiation• Lead regular account review meetings with customers to ensure that contractual terms and service level agreements are met or exceeded; suggest additional products/services to deepen customer relationship• Identify customer relationships currently at risk; lead the efforts with the appropriate internal and external stakeholders to ensure retention of the current customer base• Participate in best practice sharing, process improvement development, and other related activities in order to build best in-class programs for Clinical Trail Service customers

Morgantown, Wv

• Designs and Implements plan to supply study drug to global clinical trials utilizing sound supply chain techniques• 11 Years of experience in Clinical Supply with an additional 8 years of experience in Pharmaceutical R&D• Utilizes an extensive network in the pharmaceutical industry to generate and cultivate relationships for Clinical Supply Operations• Expertise in clinical trial supply chain management, including managing complex supply chain activities for global clinical trials• Oversight of Import/Export Activity for Global Clinical Supply Shipments, Management of temperature requirements for complex shipments. • Gathers and analyzes financial information pertinent to budgeting and forecasting activity for global clinical supply chain• Manages the execution of complex first to file clinical trials requiring the highest degree of focus, strategy and confidentiality• Develops strong internal collaboration with key stakeholders across all functional units of R&D, manufacturing, PK/DM, Clinical Operations, Quality and Regulatory• Proactively identifies issues with the potential to impact clinical development programs and engage with key stakeholders and executive management to identify risks and create solutions• Administers the performance management, career development, training and day to day activities of the Clinical Supply Operations Staff• Oversees vendor management relationships across more than 40 vendors ranging from comparator sourcing, transportation logistics and ancillary supply vendors• Understands relevant cGMP, GCP, GDP and other requlatory requirements. Understands high level import/export requirements for global distribution of clinical supply

Morgantown, Wv

Oversee the duties and responsibilities of the support staff for the procurement, shipment or handling of clinical supplies.Advise, instruct and train personnel regarding purchasing policies, procedures and logistics.Monitor and oversee the purchase of brand drug supplies for accuracy, as established in the Procurement guidelines. Communicate with all departments throughout the Company to provide assistance with procurement and shipping related questions.Responsible for vendor management and oversight related to clinical supplies. Oversee the scheduling of meetings with vendors and manufacturers to discuss forecast requirements, product issues, and negotiation of supply agreements as required.Oversee budgetary spend and ensure cost efficiencies for global product procurement and shipments.Authorize and sign purchase orders within an established limit. Initiate confidentiality agreements, negotiate pricing, and establish contracts with suppliers where appropriate.Attend project meetings and ensure required product is available for upcoming clinical trials. Assist clinical project team with release of clinical supplies to investigator sites according to applicable guidelines and regulations.Ensure appropriate paperwork is completed prior to all drug shipments. This includes ensuring all appropriate Controlled Substance paperwork is in place and/or any local regulatory requirements (US and ex-US) regarding licenses, etc are met before shipping the drug products.Oversee the maintenance of drug inventory and storage of all clinical dosing supplies. Manage various spreadsheets to track drug supply procurement activity.

Morgantown, Wv

Responsible for Global Drug Procurement for all MPI Groups, which includes working with various vendors to obtain price quotes, negotiations, contracts and establish procurement processes, conducting price comparisons for larger quantity orders, processing invoices, and creating Purchase Orders using SAP. Responsible for the coordination of Clinical Drug Supply Orders, Shipments, and Release. Responsible for the Import/Export of global drug supplies to various locations around the world, which includes creating Clearance Documents, Air Way Bills, Commercial Invoices, etc. Responsible for the Tracking and Procurement of difficult REMS Products. Responsible for the Annual DEA Inventory for all Clinical Supplies. Supervise the duties and responsibilities of the support staff for the Global Drug Procurement group. Organize and distribute equitable work assignments and provide training as required. Responsible for the creation and maintenance or various spreadsheets for drug procurement tracking, drug procurement budgeting and overall budget spend for Global Drug Procurement.

Responsible for Global Drug Procurement for all Subsidiaries, which includes working with various vendors to obtain price quotes, negotiations, contracts and establish procurement processes, conducting price comparisons for larger quantity orders, processing invoices, and creating Purchase Orders using SAP. Responsible for the shipment of global drug supplies to various locations around the world, which includes creating Clearance Documents, Air Way Bills, Commercial Invoices, etc. Responsible for reconciliation and delivery of all purchased drug product. Responsible for the creation and maintenance or various spreadsheets for drug procurement tracking, drug procurement budgeting and overall budget spend for Global Drug Procurement.

Responsible for processing of all Master Service Agreements and contracts for US and EX-US PK/DM studies. Responsible for obtaining quotes from various vendors. Responsible for the maintenance of various tracking spreadsheets used for reports, contracts, and invoice reconciliation. Responsible for processing all payments for all contracts, which includes, creating the accounts in SAP, obtaining approvals for contract quotes, processing invoices through accounting and tracking of the overall spend for budgeting purposes. Responsible for routing all contracts for signatures to Executive Level Officers. Responsible for the maintenance of the Clinical Trials Website Information, which includes data entry for all marketed products within the State of Maine.

Support the Senior VP of Research & Development which includes maintenance of his calendar, scheduling of meetings, generation of various customized reports and PowerPoint presentations, maintenance of raw material budgeting and purchasing information, assist in the building and tracking of Research & Development annual budget. Scheduling of interviews, coordinate travel arrangements. Processing of expense reports, invoices, and credit card purchases for entire R&D Administration Department. Referencing of information from the library and various research programs. Acts as a resource to the Research & Development departments on various software applications.

Supports the VP of Product Development which includes maintenance of his calendar, scheduling of meetings, maintenance of various weekly and monthly project tracking reports, maintenance of raw material budgeting and purchasing information, assist in the building and tracking of Product Development annual budget. Coordinates and assigns duties to the Product Development Clerk. Implemented and maintains a Tablet and Capsule database used in Tradedress selection. Schedules interviews, coordinates travel arrangements. Implemented and maintains a Product Development Raw Materials inventory system at Collins Ferry for inactive, active drug substance and finished product. Responsible for ordering office and lab supplies, business cards and other supplies as necessary. Processing of expense reports, invoices, and credit card purchases.

Education record

Diploma, Legal Office Technology

Civil Trial Practice, Real Estate Law, Criminal Law, Legal Research and Writing I - II, Typing I - II, Legal Typing and Transcription.