Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and trouble-shooting.

Leads weekly customer calls and CPT meetings in absence of Project Manager.

Creates notes for weekly customer teleconference calls and internal CTP meetings.

Creates project specific documentation including packaging specification, variable data form, sample shipment request forms, monthly finished goods inventories, logistic management document, returns accountability worksheet, monthly distribution billing spreadsheets.

Manages timing of internal process to ensure timely receipt and release of bulk, project packaging components and shipping supplies.

Communicates with customers and vendors to resolve missing or erroneous certs and documentation related to receiving and QC release of bulk, packaging components and shipping supplies.

Monitors and updates scheduling liaison with production needs for project.

Creates project specific routings and bills of material.

Works closely with internal groups and vendors to ensure project milestones are achieved, including labelling and component design and delivery and on-time shipments of order requests.

Hard allocates lot specific bulk and material to the work order.

Works with customers and sites to resolve discrepancies on end of study returns.

Creates Inventory Disposition Report and forwards to customer for destruction approval of returns, remaining finished goods and customer owned inventories.

Processes monthly distribution invoices and records data in project specific metrics.

Resolves shipment delivery issues by working closely with DSA group, carriers, customer and clinical sites.

Assumes the role of the client advocate and acts as secondary client communication point for clinical packaging, storage, and distribution for assigned projects. Acts as back-up Project Manager contact for internal communications and trouble-shooting.

Accountable for assigned project tasks using appropriate project planning tools.

Host and manage customer visits at PCI.

Training and on-boarding of new employees within same role, as requested.

Maintains and updates project plans and timelines as requested.

Knowledge of and adherence to all PCI, cGMP and cGCP policies, procedures, rules and regulations as applicable to assigned clinical projects.

Attendance to work is an essential function of this position.

Performs job duties as assigned by Manager / Supervisor.

GCSE Grade C and above in English, Science and Mathematics (or equivalent, e.g. German Mittlere Reife/Realschulabschluss) is essential.

A Level/NVQ/HNC or equivalent (e.g. German Abitur, Fachhochschulreife, or relevant Berufsausbildung) in Applied/Life Sciences or Mathematics is desirable.

Experience in a supportive role, preferably in the clinical supply field and a contract 
environment. 

An understanding of Quality Standards including GMP, GCP and GDP. 

Experience in providing administrative support 

Clear and concise communications

Attention to detail 

Proficient in the use of MS Office Packages