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.

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.

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.

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.

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.

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.

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 in.

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.