Clinical Trial Supply Specialist

2 settimane fa

Milano, Lombardia, Italia Recordati A tempo pieno 60.000 € - 90.000 € all'ano
Job Purpose

We are looking for a Clinical Trial Supply Specialist who will manage the IMP supply chain for assigned clinical studies throughout the multi-year study lifecycle to ensure a compliant, on-time supply of drug supply and ancillary materials, ensuring proper packaging, labelling, shipment/storage/accountability/return/destruction of drug supply (IMP, AxMP, N-IMP) in the global clinical trials sponsored by Recordati Group and ISSs

Key Responsibilities


•    Manage the IMP supply chain for assigned clinical studies 

•    Ensure that all activities are performed in compliance with GCP/GMP/GDP guidelines and other applicable regulations; and in line with the budget estimate and timelines, as defined in the approved research programs.

•    Manage the CMO selection process, starting from the identification of the CMOs for the tender, the signature of the Confidentiality Disclosure Agreement (CDA), preparation of the Technical Specifications, execution of the bid defence meetings, technical assessment, until the endorsement of the final decision and Service Agreement and Quality Agreement signature.

•    Define the production, logistics and distribution plan to ensure delivery of IMP in accordance with the planned timelines, including importation and customs clearance tasks

•    Define the packaging specification and kit design in collaboration with the other functions of the study team.

•    Define with IT Digital Solutions and Data Management the Randomization and Trial Supply Management (RTSM) system specifications; actively involved in the implementation and configuration of the RTSM system and changes if any.

•    Prepare in collaboration with other applicable functions study plans, manuals and forms for the management of IMP.

•    Execute and coordinate IMP complaints, batch recalls, change controls.

•    Renew and prepare new SOPs, WIs for IMP processes.

Required Education

Bachelor's degree

Required Skills and Experience


•    5+ years' experience in the CRO/pharmaceutical industry

•    Background in clinical operations/supply chain with investigational products

•    Good communication skills and working within a cross-functional team

•    Knowledge of GCP/GMP/GDP guidelines, EU and FDA regulations, drug development process

•    Ability to work within multidisciplinary teams, coordination of internal and external stakeholders (CMO/CRO/vendors)

•    Proven aptitude for problem solving and decision making

•    Strong operational skills and ability to meet timelines

•    Good knowledge of Veeva systems: CTMS, eTMF, QMS, CDMS, RTSM

•    Experience reporting project details to various stakeholders within company and outside of the company

Required Languages

Fluent in English


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