Clinical Trial Supply Specialist

*With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking 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, 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

At Recordati we believe in people Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, 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.