● Working closely with Project Managers and Functional Leaders to ensure high-performance standards and quality deliverables in the management of global clinical trials spanning Phase I-III.● Supporting risk and issue management.● Managing various aspects of Project Finances including invoices, reconciliation and purchase orders. Supporting project manager in identifying Out of Scope activities.● Cultivating robust relationships with internal and external stakeholders across regions facilitating seamless project coordination and alignment with strategic objectives.● Preparing and delivering project status reports, meeting agenda and minutes for internal team and customers.● Improving the integrity of the trial master file (TMF) by meticulously managing its contents, conducting regular reviews, and liaising with stakeholders to address any discrepancies or deficiencies.● Exhibiting flexibility and organizational skills by effectively managing concurrent projects, adeptly prioritizing tasks, and swiftly addressing emerging issues to uphold project timelines and objectives.● Playing a pivotal role in tracking, measuring, and evaluating project metrics in collaboration with Project Managers, offering strategic insights to optimize study progress and mitigate risks.● Providing invaluable support to Project Managers in identifying changes in scope, adhering to project timelines and financial goals, and orchestrating client and investigator meetings.● Facilitate team training initiatives, maintaining a project-specific training matrix, and ensuring compliance with training requirements to enhance team proficiency and performanceResults achieved:• Leading successful sponsor TMF audit.• Lean Practitioner Training.

As a life science reviewer/translator I have the main responsibility to guarantee high standard translation of clinical trial, drug safety and regulatory documents (ICFs, protocols, agreements, reports and regulatory documents) within predefined deadlines.

I worked in projects related to research and development of biotechnological pharmaceutical products. Broad technical and scientific, project management and relationship with stakeholders.

• Management and conduction of heart tissue proteomic analysis;• Compiling results, analyzing data to prepare technical reports and presentations to internal and external stakeholders;• Writing reports and research projects to attract funding.

• LDL purification using HPLC, immune response analysis, statistical analysis and writing scientific reports.