Paula M. Moncaleano Email & Phone Number

Belgium

Oversee a Pan-European Data Registry, ensuring data collection, quality, and security in compliance with European regulations. Provide technical guidance to external IT stakeholders to enhance registry technology, manage API-based connections, and implement system features. Support the registry’s implementation by developing risk management plans, data sharing procedures, and audit strategies, while overseeing data governance in alignment with GDPR, which covers the Data Protection Impact Assessment (DPIA). Lead the creation of user-friendly data visualization tools for stakeholders and drive proposal writing to secure additional funding from the European Commission. Additionally, oversee database improvements through SQL coding and develop Power BI dashboards to provide efficient data visualization and reporting.

Netherlands

Develop collaboratively code for quantitative genetics, data analysis, and visualization of datasets. Test models to predict phenotypes and develop predictive phenotypes through the study and comparison of predictive models. Turn data into actionable insights and communicate it to a wide audience. Specialize in developing and comparing predictive models based on historical data to optimize data, enhancing quantitative genomics for resistance.

Training project for health care professionalsDeveloping and implementing a comprehensive global specialized training program for healthcare professionals, encompassing sponsor, third-party entities and Contract Research Organizations (CROs).

Merge and acquisition - Safety Information Transfer and Data MigrationSuccessfully achieved the transfer of all safety information from Actelion to Janssen in alignment with company policies, local, and global regulations, while ensuring compliance and operational continuity through comprehensive training of the local team on Actelion case handling.Key Responsibilities:Facilitated data transfer processes during the merger and acquisition.Led data migrations between different databases and data repositories for product registration and post-marketing follow-up.

Trained first-line healthcare workers to collect, upload, and process adverse event information according to company procedures, ensuring timely and accurate processing. Conducted technical triage of incoming adverse events, defining seriousness and processing timelines. Ensured submission of adverse events and product quality reports in compliance with FDA, EMA, and local regulations through meticulous data capture and causality definition. Liaised with key stakeholders for safety data collection and reconciliation. Provided pharmacovigilance training to non-drug safety staff and crafted evidence-based responses to medical inquiries using scientific literature. Played a pivotal role in implementing the Global Medical Information system for cardiovascular, respiratory, and rare diseases.

In-House Initiative: Leading Training Programs for Product Owner Members. Actively trained new hire waves from 2016 to 2019, ensuring comprehensive certification in Clinical Data Management following industry standards and company protocols. Additionally, provided mentorship to new trainees and junior staff, delivering tailored training to both local and remote teams in quality assurance, data review, analysis, and FDA-EMA registration processes.

Colombia

Executed comprehensive end-to-end data management activities for oncology clinical trials, contributing to FDA approval in multiple protocols. Implemented data integrity procedures, including data collection, query management, and reconciliation across various platforms. Provided direct support to research centers, coordinated site-level communications, and assisted lead clinical data managers. Ensured compliance with regulatory guidelines, including FDA and EMA regulations, throughout trial phases.

Pathogenicity assays, design and execution of experiments, effectiveness assays to test new biological controllers using molecular techniques for the implementation of protocols.

Entomology Curator at the Museum of Natural History, specializing in Coleoptera with a focus on taxonomy, responsible for managing and expanding the beetle collection, conducting research, and sharing findings through exhibits and educational programs.

Master Of Science - Ms, Genomics

Activities and Societies: Biosystematics group.Master's degree in Life Science, specialized in genomics and data science. Skilled.

Bachelor Of Applied Science (B.A.Sc.), Biology

Bachelor of Science graduate with a specialization in pathogenicity research aimed at disease control. Proficient in employing molecular.