Role Overview

A leading multinational pharmaceutical company is seeking a Clinical Supply Specialist to support the end-to-end management of investigational medicinal products across clinical trial phases.

The Clinical Supply Specialist is responsible for coordinating the packaging, labeling, and distribution of investigational medicinal products (IMPs) for clinical trials. He/she supports clinical trial logistics, ensures compliance with GxP standards, and collaborates with cross-functional teams to maintain supply chain integrity throughout all study phases. The role is based in Albania and operates in an international context, supporting clinical supply activities for clinical trials conducted outside Albania.

Key Responsibilities

· Monitor inventory levels and manage resupply planning to ensure uninterrupted study drug availability.

· Support the creation and maintenance of clinical supply documentation, including packaging specifications and distribution plans.

· Collaborate with cross-functional teams (e.g., Clinical Operations, Quality, Regulatory Affairs) to align supply activities with study timelines.

· Ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other applicable regulatory requirements.

· Track shipment status and resolve logistics issues with depots, couriers, and vendors.

· Assist in forecasting drug demand based on enrollment projections and protocol requirements.

· Maintain accurate data in supply chain management systems and support audit readiness.

· Participate in the development and review of Standard Operating Procedures (SOPs) related to clinical supply processes.

Education

· Bachelor's or Master's degree in Chemistry, Pharmaceutical Chemistry and Technology (CTF), Biological Sciences, or a related discipline.

· At least 3 years of experience in a similar role, preferably within the pharmaceutical or life sciences sector.

Technical Expertise

· Fluency in Italian and English (written and spoken).

· Proficiency in main productivity and collaboration tools (Google Workspace, MS Office).

· Knowledge of Project Management tools and methodologies.

· Familiarity with main equipment used in pharmaceutical production.

· Knowledge of drug procurement models.

· Knowledge of GCP, GMP, and GDP standards.

· Knowledge of pharmaceutical regulations and the broader pharmaceutical sector.

Core Competencies and Skills

· Strong organizational skills and attention to detail in managing complex supply chains.

· Ability to work effectively within cross-functional and multicultural teams.

· Problem-solving mindset with a proactive approach to logistics and supply challenges.

· High level of accuracy and commitment to data integrity and audit readiness.

· Effective communication and stakeholder management skills.

· Adaptability and ability to manage multiple priorities in a fast-paced environment.

· Professional integrity with a focus on quality, compliance, and patient safety.

Working Conditions

· Hybrid (onsite/remote) working model.

· Competitive salary package offered.

· Requires flexibility, adherence to deadlines, and strong cross-functional collaboration.