Job Overview:Summary of Responsibilities:- Understand and follow, provide input to and training of related project specific and Fortrea policies and procedures.- Direct line management responsibility for Clinical and Ancillary Supply Services team members; the recruitment, training/development, allocation, supervision, utilization, and performance review of assigned personnel.- Effectively network with others throughout Fortrea.- Serve as primary liaison between Clinical and Ancillary Supply Services, operational project teams, Fortrea Laboratory Services (CLS), distribution vendors, client distribution units, packaging and labeling vendors or assign relevant staff to carry out this function.- Liaison with project teams and department members regarding issues of compliance with ICH/GCP, GMP, project plans, and Fortrea SOPs.- Oversee coordination of study related Clinical and Ancillary Supply activation and maintenance components including Labels/Supply, Import/ Export requirements, ancillary supply management.- Develop project specific plans for the Clinical and Ancillary supply component of assigned studies.- Represent Clinical and Ancillary supplies component within a region or for complex global studies at client and internal project meetings.- Anticipate and monitor project requirements and institute appropriate actions to ensure timelines and budget needs are met.- Contribute to the development of processes, procedures, tracking systems and IT solutions for Clinical and ancillary supply activities.- Assist in the preparation and presentation of services, costings, and proposals for new business.- Management of relevant portion of project budgets, including input into preparation of utilization reports (projected and actual)



and implement measures to ensure accurate billing.- Interact with internal and external work groups to evaluate and forecast workload and resource needs.- Present at internal and external meetings including client meetings.- Ensure appropriate communication on project-related matters with the clinical project team.- Provide clinical and ancillary supply project related milestone information.- Review and, in accordance with Fortrea standards and assigned authority, approve employee expense reimbursement.- Clinical trial supply and ancillary supply coordination:- Provide consultation pertaining to clinical and ancillary supplies: the labeling, tracking, specific national requirements, importation.- Review IxRS specifications.- Ensure triggering of drug shipments to investigational sites.- Manage Drug distributor.- Supervise development and review of Clinical Trial Supplies Plans.- Review of and input to authority inspection and client audit findings or CAIRs.- Develop, update and/or refine SOPs.- Remain current with and provide updates to regional and local regulatory requirements related to clinical and ancillary supplies.- Remain current with industry innovations and advances,



especially pertaining to clinical and ancillary supply matters so as to include relevant advances and technology into the design of trial strategies.- Maintain relationships with comparable levels at client organizations to ensure effective relationships.- Build and develop relationships with new clients to bring in new business.- Serve as an escalation point for project issues.- Involvement in strategic partnership discussions.- Input into client projects.- All other duties as needed or assigned.Qualifications (Minimum Required):- University/College Degree (preferably postgraduate degree) AND 4 years relevant clinical research/GMP experience.- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.- Thorough understanding of global drug development and the clinical trial project management process, with a special emphasis on investigator sites, patient recruitment and retention.- Thorough and practical working knowledge of ICH-GCP Guidelines, Clinical GMP, including relevant international requirements/guidelines for the conduct of global clinical development programs.- Language Skills Required:- Speaking/Writing/Reading: English + local language.Experience (Minimum Required):- Minimum of 4 years relevant clinical research experience in a pharmaceutical company/CRO, including at least 2 years of clinical and ancillary supplies management responsibility.- Very strong technical writing skills and analytical skills.- Strong networking abilities and an ability/willingness to work with individuals across the globe.- Excellent communication, planning and organizational skills.- Ability to inspire, to lead by example and motivate teams to seek solutions and get results.- Strong abilities to negotiate and liaise with customers in a professional manner.- Experience in end to end (full service) clinical trial management, ideally with integral project management experience.- Abilities to review/analyze rele

📌 Logistics Manager (Buenos Aires)
🏢 Fortrea
📍 Buenos Aires