Main Responsibilities: - Manage members of the multidisciplinary project team: data management, start-up, transportation/logistic, regulatory affairs and quality assurance; - Define and monitor the scope of the project, schedules and results from the initiation until closure; - Schedule, plan and document project team meetings; - Perform quotation, vendors identification; - Support commercial and operational department during the viability period of clinical trials; - Review commercial proposals; - Review and manage contracts with sites and suppliers; - Participate in the preparation and review of documents related to the project: budget, protocol, TCLE, forms, CRF, qualification reports, monitoring, and others; - Develop and implement corrective actions to maintain the quality of the project.

Consultant developed tasks:+ Participate in training related to applicable medical and regulatory documents;+ Review activities of medical department as: compare packages of medicines dose, all content (according to regulatory requirements);+ Perform all updates/work instructions in accordance with Regulatory team and Medical Manager; + Reviewed and completed comparison between kinds of medicines (generic and reference);+ Verify queries related to the portuguese language.

CRA and Lead CRA Developed tasks:+ Monitoring, Site selection, Initiation and close out visits;+ Participate in Audit visits;+ Site management and performance (including documentation) activities for multiple investigational sites in accordance with designated project assignment (including applicable SOPs, GCP and applicable international/national regulatory requirements);+ Participate in clinical monitoring staff meetings, project team meetings andclinical training sessions;+ To maintain awareness of overall developments in the field of clinical research;+ Knowledge of all assigned monitoring responsibilities, GCP/ ICH guidelines and their application and associated SOPS;+ To perform administrative duties including attendance at clinical monitoring staff meetings;+ To assist in coordination of translation of applicable study documents, for example consent forms, as required;+ Contact with PIs and all the involved staff in the sites;+ Attendance of teleconferences with Study Manager, Medical Monitors and all site staffs involved in the study;+ Assistance in solving pending issues and requirements from ECs by contacting central team, site staff and project team;+ To perform other tasks, as assigned by Study Manager.

Coordination Developed tasks:+ Clinical trial preparation involving the planning, assembling and instruction of the trial team, evaluation of patient information;+ Regulatory and ethical submissions, procedures and communicating with relevant authorities;+ Implementation of the clinical trial from initiation through the stages of development documents, SOPs, tools, organization, facilities and licenses;+ Coordination and management of the clinical trial, communication with sponsor and authorities,+ Data collection registration and management of source documents.