Contributes to the operational flow and ensures streamlined drug supply throughout the execution of the clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities/guidelines, and applicable SOPs/WPs.Responsibilities:Drug Supply responsibilities:Together with the Clinical Project Manager of the Medical Department, responsible for the financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline.Responsible for the set-up and monthly maintenance of Drug Supply Global Planning and Forecast for each Clinical Trial projected and conducted at the Medical Department.Centralize the obtention and archiving of any applicable study drug documentation (CoAs, Import/export licenses, drug dispensation form, and drug reconciliation Forms).Management of Drug Supply activities within the Clinical Trials environment (support on vendor contract management and setup definition, ownership of operational).Lead the selection and management of relationships with Innovator and ancillary drugs and/or devices suppliers (Wholesalers) within the Clinical Trials, together with Insud Pharma Purchasing and mAbxience Research SL Quality Assurance Departments.Lead the selection and management of relationship with Transport provider.Responsible for the procurement of in-house Investigational Medicinal Products, Innovators, and/or ancillary drugs and/or devices as required for Clinical Trials and/or mAbxience Research SL Medical Department Bioanalytical activities. Ensure drug supply via Global Planning and forecast to Investigational sites as required per each Clinical Trial conducted within the Medical Department.Responsible for the setup and maintenance of the Drug Supply Chain operational for each Clinical Trial including import/export licenses management, labelling and kitting campaign planning, and appropriate distribution according to established clinical protocol specifications.Responsible for organizing returns/destructions, at the end of the study to a central or local depot, as applicable, of expired or unused study drugs.Develop and Manage Clinical Supply Chain tools to consolidate global, product and clinical trial specific drug supply tracking reports and keep all of them updated on a monthly basis.Periodic monitoring of global clinical supply inventory at the central and local depot as well as at clinical site level for both IWRS and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly.Coordinate drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs, as required.Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial.Serve as 'consultant' for managers throughout the organization on issues related to clinical supplies.Support the Clinical Operations team with the setup and maintenance of the Product, Trial and required vendors' electronic and paper files.Support Clinical Operations team with the set-up and maintenance of stock tracking reports throughout the conduct of the clinical trial.Support Clinical Operations team with the organization and logistics of Clinical Study Investigator Meetings.Qualifications:Education: Degree in Administration and/or Supply Chain or related subject functions.Languages: Fluent Spanish and English, any other language is an asset.Experience (years/area): 1-3 years of experience in Clinical Trial Supply Chain or related functions preferred.Specific Knowledge: Knowledge of Clinical Trial legislation and CGPs and of shipment, import/export, and labelling activities. Knowledge of project management and Clinical customer relationship building. Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint, MS Project, and Access).Travels: 0-5%.Personal skills: Good interaction and team working capacity, ability to multi-task, demonstrated strong organizational skills and ability to independently prioritize work, attention to detail, excellent communication skills, accuracy, flexibility and openness to changes. Keeping focus in changing environments and experience in conflict resolution and negotiation skills.
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