In this vital role, you will serve as Sr Associate, supporting the Design and Setup of the Clinical Supply Chain. 

Reporting to the Manager Clinical Supply Chain-Change Mgt, and directed by the Global Setup Leads, you will contribute to the execution and completion of key deliverables associated with setup activities of global supply chains for clinical trials, by leading information gathering across stakeholders such as R&D, Regulatory Affairs, Site Supply Chain and Master data, and task close out. 

In close collaboration with the Global Setup Lead team, you will ensure reliable, compliant, and right-first-time process execution, transparent status reporting on progress, and pro-active identification of risks and mitigation strategies for closing out deliverables. 

The role is accountable for managing various deliverables such as: 

Master data requests for product materials, Bill of Materials (BOM), and study related attributes in SAP.  

Creation of the Clinical Artwork requests and facilitating prioritization of outstanding attributes in relation to the request form. 

Creation and maintenance of Product Specification Files, and Depot Plans. 

Roles & Responsibilities 

Master Data in ERP (SAP) 

• Central focus point for ERP (SAP) readiness: 

• Initiate clinical label material requests; 

• Requesting Finished Drug Product Materials, Bill of Materials (BOM), Work Breakdown Structure (WBS) elements, Custom Values and ensures timely availability to adhere to overall project timelines 

• Ensures setup of Study Design Tables. 

Setup Activities 

• Coordinate and prioritize artwork creation process via initiation and routing of clinical artwork creation request forms, facilitating discussions to resolve issues and following up on outstanding queries.  

• Creates and maintains Product Specification File Study throughout the life cycle of the clinical trial 

• Creates and maintains third party depot plans and cross docks to support global study footprint 

Reporting 

• Maintains Metrics for Global Setup lead team 

• Contributes to monthly Workforce planning cycle 

Qualifications 

• 5+ Years of experience with Bachelors Bachelor degree or equivalent in logistics, business administration or life science.  

• Typically relevant working experience, preferably in the biotechnology or pharmaceutical industry,  

• Typically relevant working experience in an international and regulated environment 

• Understanding of fundamentals of logistics/supply chain principles (especially BOM) 

• Experience in planning 

• Experience in project management techniques  

• Advanced experience in MS Office applications (Word, Excel) 

• Fluency in English, both in oral and written communication 

• High quality standards with regards to work 

• Ability to set priorities and timely escalation 

Preferred requirements 

• Knowledge of clinical supply chain management 

• General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, International Conference on Harmonization (ICH) guidelines, Clinical Trial Directive) 

• Experience in using SAP 

• Excellent communicating and facilitating issue resolution skills