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 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

Sr Associate Clinical Supply Chain Support Office