The Sr. Clinical Supplies Lead in Clinical Supplies Management is responsible for overseeing the clinical supplies for assigned studies within the Medical Device Portfolio. This position secures the supply for assigned clinical studies within the portfolio through planning, inventory, distribution and optimized risk management. This position is also responsible for managing IRT requirements for studies within the Medical Device Portfolio
Oversees all aspects of clinical supplies management ensuring there are sufficient supply levels at sites and depots.
Represents clinical supplies function at clinical trial team meetings; communicates plan and timelines to internal and external customers and partners.
Reviews clinical trial protocol and provides input to clinical supplies and IRT sections.
Creates forecasts and packaging design based on study needs to ensure optimized supply plan in terms of cost, feasibility and overage.
Proactively drives the labeling, packaging, release, distribution and return of clinical supplies for assigned studies, ensuring the project timeline is met or exceeded.
Participates in cross functional teams and provides guidance on best practices for clinical supplies management.
Leads process improvement initiatives and training efforts as a clinical supplies SME.
Supports internal/external inspections and audits.
Evaluates IRT feasibility and recommends the best option for each study
Provides guidance to cross functional teams on IRT best practices and trends
Coordinates internal meetings with Clinical Trial Team members to review and approve IRT specifications or configuration reports
Configures internal in-house IRT system per study needs and works very closely with Data Management to reach optimal design
Understands and can easily navigate across various IRT platforms
Proactively communicates timelines and ensures IRT related tasks or deliverables do not fall on the critical path
Leads process improvement initiatives and training efforts as required, including preparation of training materials
Prepares and performs User Acceptance Testing (UAT) plan for in-house IRT system
Plans and/or reviews UAT Plan for other IRT platforms and conducts the UAT with the required Clinical Trial Team members
Maintains required documents in a manner consistent with cGMP, 21 CFR Part 11, Annex 13 as well as internal QM, Corporate and Functional level SOPs.