Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for a
R&D Contracts and Sample Logistics Specialist
The R&D Contracts and Logistics Specialist will be responsible for managing and coordinating international shipments of biological samples for clinical and preclinical studies, as well as providing comprehensive support for R&D contracting activities. This role requires a strong understanding of customs regulations, import/export procedures, and contract management, ensuring compliance and efficiency in both logistics and contractual operations.
MAIN ACTIVITIES AND RESPONSIBILITIES
Working in close collaboration with the Clinical Operation team assigned to the R&D trials, the Pre-clinical and Translational department, and the Clinical Pharmacology & DMPK function, manage and coordinate international shipments of biological samples (tissues, blood, bodily fluids, etc.) for clinical and preclinical studies, ensuring compliance with national and international regulations and Good Clinical Practice (GCP) guidelines.
Prepare and manage the documentation required for shipments, including permits, certificates of analysis, and other documents required by competent authorities.
Collaborate with freight forwarders, couriers, and laboratories to ensure safe and timely transport of samples, monitoring shipments and resolving any issues.
Ensure proper storage and traceability of samples during transport, respecting the required temperatures and storage conditions.
Maintain up-to-date documentation and databases related to shipments, ensuring compliance with regulations and quality standards.
Provide internal support and advice on customs regulations and import/export procedures for biological samples.
Collaborate with the research and development team to plan and manage sample shipments for new clinical and preclinical studies.
Manage and maintain contacts with competent authorities to obtain necessary permits and authorizations.
Contracting:
Support the contracting process for R&D activities, including Confidential Disclosure Agreements (CDAs) and Key Opinion Leader (KOL) agreements.
Monitor and maintain the R&D contracts tracking system (CDAs and Contracts Agreements), ensuring prompt renewal when needed.
Assess the feasibility of implementing an integrated tracking system across different R&D sites (new project).
JOB REQUIREMENTS
Bachelor's degree in Biological Sciences, Biotechnology, Pharmacy, or related disciplines.
At least 3 years of experience in managing international shipments of biological samples for clinical and preclinical studies and/or R&D contract management.
Excellent knowledge of English, both written and spoken.
In-depth knowledge of customs regulations related to the import/export of biological samples.
Knowledge of GDP and GMP regulations related to the transport of biological samples.
Basic understanding of pharmaceutical R&D processes.
Analytical skills, quick understanding of complex issues, ability to work in a team.
Location – Pomezia, hybrid position
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