Clinical Supply Coordinator (m/w/d)
Posted on Oct 28, 2020 by ITech Consult
Clinical Supply Coordinator (m/w/d)- supply chain management/healthcare management/GMP/English/German
The Clinical Supply Coordinator (CSC) leads the operational coordination and execution of all in-house packaging activities of Investigational Medical Products (IMPs) for global and local studies. This includes an effective and efficient set-up of clinical packaging designs as well as the coordination of the availability of all bulk and packaging material to ensure a timely production and delivery of released IMPs to depots in accordance with local standards and regulatory requirements. The CSC is responsible for all tasks related to packaging order management within the planning time fence.
Tasks & Responsibilities:
Main responsibility: Ensures the timely global supply of clinical trials with IMPs. This includes
. Manages in-house packaging orders and drives the "on-time in-full" delivery of those.
. Ensures the Packaging Design Feasibility through the set-up of new packaging designs and solutions for new molecules and the required dosage forms in cooperation with the Clinical Demand&Supply Leaders, Head of Operations and Global IMP QA. Advances the implementation of corresponding new packaging designs in the Clinical Supply organization.
. Actively participates global and local Projects and Kaizens to optimize Clinical Supply. Leads in some cases local Projects specifically to improve in-house packaging.
. Responsible to escalate any major in-house packaging related issue to the Head Clinical Supply Execution Management.
. Drives and leads the issue management and process improvements for packaging topics.
. Is in charge of scheduling and coordinating Stock Transfer Orders and Sales Orders for bulk and sample shipments.
. Actively participates regular meetings with Clinical Demand&Supply Leaders, Quality Units and other Clinical Supply Operation Management teams. Is responsible to bring up all packaging related issues and drives the solution implementation for those.
. Actively manages the relationship and exchange of ideas, processes, issues, etc. with the Clinical Demand&Supply Leaders in South San Francisco to ensure an efficient supply for Genentech managed studies via the Kaiseraugst packaging facility.
. Works independently on system improvements in SAP CLARA P96; creates and revises SOPs/SPTs and training documents for CLARA P96 trainings and leads those.
. Actively monitors in-house packaging coordination related metrics and KPIs and initiates improvement actions for any KPIs under target.
. Participates proactively in weekly team huddles to support KPI tracking and Continuous Improvement. Works independently and self-motivated on ideas for process improvements and its implementation according to the Roche PT LPS (Lean Production System) initiative.
Responsibility for all operational parts of studies with regards to in-house packaging orders:
* Responsible to coordinate readiness of bulk material/label availability.
. Requesting material master data and bill of materials with the Master Data team.
. Coordinates the label development and supply in close collaboration with the Label team.* Is in charge of the Medication Randomization Management.
. Responsible for production planning and scheduling for in-house packaging in cooperation with the Head of Operations and Master Production Planner.
. Is in charge of the correct data maintenance of all study-related packaging orders in the "Clinical Packaging Plan" Tool (CliPP).
. Briefs the Order Preparation and Packaging Operations team with detailed packaging order instructions.
. Responsible for coordinating the destruction of bulk material and labels located at the Kaiseraugst packaging facility.
. Leads the internal communication of timelines for in-house packaging activities.
. Is in charge of the overall time management for all in-house packaging orders in cooperation with the Head of Operations.
* Associate level of professional education or University degree preferably in Supply Chain Management and/or Healthcare Management
. Minimum of 3-5 years' work experience in supply chain, life science, industrial engineering or equivalent required
. Demonstrated excellent problem solving and decision making skills
. Ability to work independently. Self-motivated, proactive, quick thinking and adaptable. Ability to set priorities and to remain flexible in stressful situations
. Excellent German and English skills
. Work experience in a GMP environment is a must
. SAP R3 and APO knowledge is beneficial
. Sound knowledge of Windows office applications
* High cultural awareness and social competence required as a cooperation and communication in complex situations with different cultures and countries (especially Northern American and Asian market) is part of the daily job.
. Well organized, high level of planning skills.
. Customer-focused, ability to create trustful relationships with business partners.
. Well-developed teamwork, collaboration and negotiation skills to communicate clearly and professionally both verbally and in writing.
Reference No.: 919777SGR
Role: Clinical Supply Coordinator
Industry: Pharma Location: Basel