Clinical Trial Supply Specialist

Overview

Clinical Trial Supply Specialist role at Recordati

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.

Recordati is a global pharmaceutical company with over 4,500 employees and turnover of over Euro 2bn. We develop and commercialise medicines to serve people living with common diseases, as well as those with rare diseases, in around 150 countries.

Recordati aims to reimagine tomorrow with new ideas, technologies and innovations to fight diseases, and to unlock the full potential of life.

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, from identification of CMOs for the tender to Service Agreement and Quality Agreement signature
• Define the production, logistics and distribution plan to ensure delivery of IMP in accordance with planned timelines, including importation and customs clearance tasks
• Define packaging specifications and kit design in collaboration with the study team
• Define RTSM system specifications with IT Digital Solutions and Data Management; involved in implementation and configuration of RTSM system and changes
• Prepare study plans, manuals and forms for management of IMP in collaboration with other functions
• Execute and coordinate IMP complaints, batch recalls, change controls
• Renew and prepare new SOPs and work instructions 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 ability to work within a cross-functional team
• Knowledge of GCP/GMP/GDP guidelines, EU and FDA regulations, drug development process
• Ability to work with multidisciplinary teams and coordinate 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 and outside the company

Required Languages

Fluent in English

At Recordati we believe in people. We are committed to creating a diverse environment and cultivating inclusion. We strive to lead with our values and help employees bring their whole selves to work and develop their potential. We are an equal opportunity employer and recruit without regard to gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.