Nathália Marques Email & Phone Number

São Paulo, Brasil

- Coordination of all areas of the clinical supplies’ lifecycle (i.e., depot set up, receipt, storage, handling, inventory management, shipment, delivery, return, accountability, destruction and final accountability) of IP and all clinical supplies, for complex studies worldwide, providing the logistics strategy for each project;- Responsible for local and global procurement of drugs, comparators, ancillary supplies, equipment purchase and rental, distribution, calibration management with… Show more - Coordination of all areas of the clinical supplies’ lifecycle (i.e., depot set up, receipt, storage, handling, inventory management, shipment, delivery, return, accountability, destruction and final accountability) of IP and all clinical supplies, for complex studies worldwide, providing the logistics strategy for each project;- Responsible for local and global procurement of drugs, comparators, ancillary supplies, equipment purchase and rental, distribution, calibration management with local & global vendors and couriers, controlling and monitoring all activities, including the financial part;- Participates in and supports department project teams, including development clinical supply strategy. Acting as a project lead, assisting in the development suggestion of process improvements and process improvement initiatives;- Acting as a mentor for other coordinators, helping with the entry of new members, I am a point of contact for clarifying doubts and discussing strategies and I also collaborate with trainings for the team;- Ongoing training on new regulations concerning all clinical supplies and GCP activities; Show less

São Paulo, Brasil

- Logistics coordination of studies worldwide, ensuring that all activities are executed in compliance with GCP, company and client requirements;- Meets with internal teams to coordinate efforts, provide insight about vendors processes and procedures, costs, timelines, requirements, recommendations of solutions to logistics challenges, risks, including development clinical supply strategy;- Represents the department internally and externally at meetings, strategic projects as per… Show more - Logistics coordination of studies worldwide, ensuring that all activities are executed in compliance with GCP, company and client requirements;- Meets with internal teams to coordinate efforts, provide insight about vendors processes and procedures, costs, timelines, requirements, recommendations of solutions to logistics challenges, risks, including development clinical supply strategy;- Represents the department internally and externally at meetings, strategic projects as per business requirements;- Establishing strong relationships with third party depots, couriers and interactions with multiple areas such as finance, contractors, clinical, import and export, quality and direct support to project managers;- Keeps control and oversight on the POs and services performed by vendors, following up on distribution plan, SIV dates, right products to be delivered and with good quality that´s required.- Acting as a representative of the department in global initiatives of the company in the change and implementation of new eTMF system, discussing the operational point of view and impacts, training the department and being a point of contact for questions and support. Show less

São Paulo, Brasil

- Responsible for planning and logistical coordination of moderate studies worldwide;- Responsible for the ordering, depot set up processes, receiving, processing, storing, shipment and delivery, return drug accountability, reconciliation and destruction of clinical supplies with global & local vendors;- Performs Global and Local Purchases for procurement of drugs, comparators, ancillaries supplies and third party depot services according to the study/sponsor requirements;-… Show more - Responsible for planning and logistical coordination of moderate studies worldwide;- Responsible for the ordering, depot set up processes, receiving, processing, storing, shipment and delivery, return drug accountability, reconciliation and destruction of clinical supplies with global & local vendors;- Performs Global and Local Purchases for procurement of drugs, comparators, ancillaries supplies and third party depot services according to the study/sponsor requirements;- Provides support to clinical supplies operations and administrative activities in all areas of clinical supplies life-cycle;- Leading all communication with the suppliers selected to support the protocols;Integrates all clinical supplies activities into the supply chain to support project logistic strategy and compliance with GxP requirements;- Completes ongoing training on new regulations concerning clinical supplies and GxP activities; Show less

São Paulo E Região, Brasil

- Coordination, support and execution of administrative work to support the department on the day to day operations of the study drug, comparators and ancillaries management of low complexity studies.- Main contact person between Project management, vendors and sites. - Studies setups, quotation requests for procurement of drugs, comparators, ancillaries supplies and third party depot services according to the study/sponsor requirements. - Keep control and oversight on the… Show more - Coordination, support and execution of administrative work to support the department on the day to day operations of the study drug, comparators and ancillaries management of low complexity studies.- Main contact person between Project management, vendors and sites. - Studies setups, quotation requests for procurement of drugs, comparators, ancillaries supplies and third party depot services according to the study/sponsor requirements. - Keep control and oversight on the quotations, PO's and services performed by vendors, following up on distribution plan, SIV dates, right products and all requirements for procurement and distribution for the study. Show less

São Paulo E Região, Brasil

- Experience with administrative routines and experimental research (development and application of Informed Consent, research protocols, reporting and accountability), conducting studies involving humans and pre-monitoring data.-Assist in conducting clinical studies in the specialty of Rheumatology, Pneumology and Gynecology; preparation of documents relevant to clinical research (Protocol and GCP deviation, protocol violation, reporting SAE) program of visits and patient scheduling.-… Show more - Experience with administrative routines and experimental research (development and application of Informed Consent, research protocols, reporting and accountability), conducting studies involving humans and pre-monitoring data.-Assist in conducting clinical studies in the specialty of Rheumatology, Pneumology and Gynecology; preparation of documents relevant to clinical research (Protocol and GCP deviation, protocol violation, reporting SAE) program of visits and patient scheduling.- Experience and theoretical knowledge in human scientific research, Good Clinical Practice and system flow CEP / CONEP- Organization and preparation of the documents for the Sponsor and Ethic Committee- Regulatory affairs- Follow-up of e mails, deadlines, spreadsheets with sponsors;- Resolution of monitoring letters Show less

- Responsible to provide specific information on an urgent basis to health professionals and the general population, in the event of poisoning, exposure to toxic substances, contamination with pesticides, accidents with poisonous animals and adverse reactions to medicines, via telephone, assisting in diagnosis and treatment.