Nicole Garrett

About Nicole Garrett

Experienced Clinical Trial Supply Manager with a demonstrated history of working in the pharmaceuticals industry. Strong operations professional skilled in Negotiation, Good Clinical Practice (GLP), Good Distribution Practice (GDP), Regulatory Requirements, Management, and Clinical Trial Supply ExpertiseExcellent negotiation skills and ability to influenceExperience working with global customersPoise and confidence in interacting with varying levels of managementTeam building and talent development

Experience

1. Senior Manager, Clinical Trial Supply

   PCI Pharma Services

   Mar 2020 — Present · US

   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.

Education

• WEST VIRGINIA JUNIOR COLLEGE

  Diploma, Legal Office Technology

  1997 — 1999

Skills

• Logistics
• Marketing
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Import Export
• Pharmaceutical Industry
• Sop
• Fda
• Regulatory Requirements
• Management
• Cross-Functional Team Leadership
• Regulatory Submissions
• Accounts Payable
• Procurement
• Clinical Research
• Capa
• Validation
• Sap
• Pharmaceutics
• Glp
• Clinical Supplies
• Change Control
• Regulatory Affairs
• R&D
• Clinical Trials
• Gmp
• Product Development
• Technology Transfer
• Negotiation