Supply Chain Manager, Clinical Trials (Hybrid)
Reporting to the Director, Clinical Supply Chain, this position is responsible for supporting multiple Clinical Development Programs in all clinical study phases. The incumbent is responsible for oversight of the supply chain planning and execution for a controlled drug investigational medicinal product as well as a medical device including ancillaries supplied globally to a broad range of clinical studies. They will act as lead point of contact for clinical supply provider vendors contracted for the execution of supply to the company sponsored clinical studies.
In addition, they shall partner with CMC and Device to manage inventory of drug substance, drug product, device and ancillaries through the program, developing appropriate systems and processes to manage inventory and maintain supply chain integrity.
Key Duties and Responsibilities:
1. In partnership with key stakeholders from Clinical Operations, CMC, Device, Quality and Regulatory oversee the development of a Clinical Supply Plan that documents the study design, product requirements, and study assumptions e.g. enrolment, target countries, number of sites, etc. for each study included in a Clinical Program.
2. Oversee the development of the clinical demand forecast on a study and program level and communicate this as required to the key stakeholders to ensure seamless coordination of demand and supply.
3. Prepare and continuously update clinical demand/supply scenarios using different combinations of inputs and assumptions to project both short-term and long-term supply requirements.
4. Monitor enrolment, drop-out rates and actual supply needs. Ensure continuous re-assessment of project needs.
5. Support regulatory filings including IMPD and IND submission information, and audits from all health agencies.
6. Support vendor management process including RFP, contract review and work orders with vendors.
7. Proactively identify issues with the potential to impact a clinical study and/or program and engage with key stakeholders to highlight risks and find solutions.
8. Design input for clinical packaging requirements.
9. Drive label creation and approvals process, including translations for all countries.
10. Monitor conformance to Clinical Supplies Inventory Management with Interactive Response Technology (IRT) standards where implemented.
11. Design, implement and oversee return and destruction of IMPs from sites.
Experience and Qualification Requirements:
1. Minimum 5-8 years of relevant experience.
2. Experience with supply management of scheduled/controlled drugs is an advantage; experience of US DEA requirements is highly beneficial.
3. Experience with leading cross-functional matrix teams is an advantage.
4. Strong organizational, communication, and decision-making skills.
5. Ability to effectively interact with all levels of internal and external management, including clinical service providers, CMO and CRO vendors.
6. Self-motivated with the ability to work in an unstructured environment.
7. Proven ability to successfully achieve results within a multi-cultural and geographically diverse cross-functional team.
8. Flexible, able to adjust, embrace and drive change.
9. Resilient, energetic, and enthusiastic.
CV to Gavin Kennedy at The RFT Group: gavin@rftgroup.ie, Phone: 01 2302400
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Supply Chain
Industries
Pharmaceutical Manufacturing
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