Amanda B. Goodman
Supply Chain Consultant
Ms. Goodman is an accomplished clinical trials material manager with experience running domestic and international drug development programs for clinical trial phases 1through 3. The clinical trial programs included management of CMC manufacturing of drug substance, drug product, labeling and packaging of clinical supplies and clinical supply distribution.
She has led the developing and implementing of IRT for all phases of clinical trials including development of randomization and stratification criteria, review and development of specifications and user acceptance testing. She is knowledgeable of cGMPs and relevant FDA regulations.
Expertise includes developing detailed electronic diary for use in phase 2 and phase 3 clinical trials for orphan disease working with vendors to develop specifications, specification review, testing script development, conducting and managing testing of the diary and assisting in trouble shooting as issues arose during the clinical trial.
- Established and maintained clinical supply chain to ensure appropriate material delivery in a timely manner for multiple clinical trials,
- Maintain appropriate supplies for clinical sites based on expiry period including management of short expiry periods and limited IMP supply,
- Worked with clinical and CMC to develop robust strategies to ensure clinical trial needs are met,
- Responsible for all IMP labeling activities including development of label content for multiple regulatory agencies and management of translations,
- Establish and modified trial specific distribution agreements,
- Lead person managing vendors and coordination between multiple sites (domestic and international) to ensure project success including managing budgets, contracts, invoices and statements of work,
- Lead person developing and implementing IRT for all phases of clinical trials including development of randomization and stratification criteria, review and development of specifications and user acceptance testing,
- Collaborate with CMC and clinical project teams to develop CTM supply requirements based on materials on hand and clinical needs,
- Manage shipments of materials to depots throughout the world, work with depots to get materials through customs and have materials delivered as sites in a timely manner.
- Supply Chain Forecasting
- Clinical Supply Protocols
- Cold Chain and Sub-Zero
- Open Label Supply Chain
- Blinded & Double Blinded
- Packaging & Labeling
- International Customs
- Global Distribution Chain
- Vendor Management