Msc. Vanessa Leite Email & Phone Number

Trier, Rp, De

Germany

• Responsible for timely distribution of IMP and clinical supplies to research sites.• Coordinate clinical document translations through the Lionbridge platform.• Extract and analyze metric data from Veeva Vault and create Excel pivot tables for process improvements.• Support clinical studies during start-up and close-out, including ISF Binder creation and essential document reconciliation.• Perform Quality Check reviews for Essential Documents in eTMF following ALCOA principles.• Ensure site compliance with study timelines, protocols, ICH/GCP, and regulations, working closely with the Study Manager.• Assist CRAs with clinical systems maintenance and data support within project timelines.• Manage Veeva Vault (eTMF) for TMF collection and compliance with GCP.• Track study progress using various systems to ensure accuracy and completeness.• Collect, review, file, and maintain essential documents in compliance with local regulations and ICH/GCP.• Support Study start-up specialists in fulfilling local submission obligations as per regulatory and IRB/IEC requirements.• Act as a liaison with clinical supply/service vendors and collaborate with functional area team members to achieve project goals.

Maastricht, Limburg, Netherlands

• Coordinating data/documents related to Clinical Studies (Coronary & Structural Heart);• Actively participating in the tracking and filing of Ethics Committees/Competent Authority submissions, study reports, and study documentation based on protocol requirements;• Creating and managing clinical study files and oversees the organization and distribution of clinical study documents;• Working with different systems including Oracle Clinical, CTSM, RAD and a broad practical knowledge of the operational systems;• Supporting the Clinical Research Specialist in periodic audits;• Ensuring timely and quality completion of data forms, verifying study data, generating, managing, and tracking data discrepancies;• Periodic review of study files for accuracy, completeness, and regulatory inspection readiness.

São Paulo

• Management of adverse events: Spontaneous cases and Post Marketing Study;• Responsible for review, entry, evaluation, and recognition of adverse events reports in Brazil as well as other countries for entry into the LSS system (Argus);• Comply with internal and external deadlines in the processing of adverse events cases and identify problems that may lead to delays in the submission of the reports;• Good knowledge of medical terminology (MedDRA);• Assessment of seriousness and expectdness of adverse events according to CORE, SPC, US and IB labels;• CATool monitoring: Responsible for monitoring products complaints related to cases aligned with Brazil Regional Center (BRC)

Santo André

• Conducting national and international clinical studies, multicenter, phases II, III and IV according to GCP, in the areas of autoimmune diseases, dermatology, infectious diseases, allergy, and diabetes;• Responsible for dispense, prepare and administration of medications;• Medication reconciliation;• Ensuring that IMPs are appropriate for use and are procured, handled, stored, and used safely and correctly;• Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow• Assisting in the evaluation of patient eligibility;• Providing support to physicians• Managing and responding to any data queries received;• Regulatory affairs and administrative duties

Campinas E Região, Brasil

• Development of scientific research projects in Parasitology area with an emphasis in Epidemiology of Schistosomiasis in Southern Brazil;• Coordinator of scientific research projects related to extension activities promoted by Unicamp;• Laboratory skills• Histology training for Ph.D. students;• Responsible for the management and maintenance of animals used in scientific research;• Presentation of projects in Science Conferences

Campinas Area, Brazil

•Teaching Parasitology classes for students in Biology course;•Support to Professor in performing academic tasks

Campinas E Região, Brasil

• Organization and maintenance of laboratory equipments;• Breeding and maintenance of animals using in Scientific Research;• Support to the technician in performing laboratory activities

Uberlândia E Região, Brasil

• Development of activities in Forensic Entomology area;• Laboratory skills• Participation in scientific research projects of masters and doctoral students within the Entomology Laboratory;• Production and publication of an article in a Scientific Journal;• Presentation of projects in Science Conferences;• Parasitology monitor for students in Medicine, Odontology and Biology courses;• Support to Professor in performing academic tasks

Master'S Degree, Parasitology

Specialization In Clinical Microbiology (Infectious Diseases), Microbiology

Activities and Societies: "Syphilis reemergence in Brazil and in the world: the etiological agent, clinical manifestations.

Fundamentals Of Clinical Trials

8 weeks course lenght. This course discuss the design, conduct, analysis, and interpretation of Phase I-IV clinical studies.

Bachelor'S Degree In Biological Sciences

English Course

Writing In The Sciences (Online Course)

This course teaches scientists to become more effective writers, using practical examples and exercises. Topics include principles of good.

Ayurveda Therapist Course, Ayurvedic Medicine/Ayurveda