Scientific Research · Clinical Research · Clinical Data Management
Carolina Ollé, PhD
PhD-trained scientist with over 12 years of academic research experience and a professional background in the pharmaceutical industry.
My expertise spans experimental research, scientific writing, clinical study documentation, and clinical data management, combining scientific knowledge, analytical thinking, and practical experience in clinical research.
One Scientific Background, Multiple Fields of Expertise.
I am a scientist with a PhD from the University of Buenos Aires and over 12 years of experience in academic research, complemented by professional experience in clinical research and clinical data management.
My academic career has focused on food science, applied microbiology, and the development and characterization of edible films and coatings. This work has involved experimental design, data analysis, scientific publishing, university teaching, and the supervision of research projects.
In the pharmaceutical industry, my experience includes the development of clinical study protocols, informed consent forms, case report forms (CRFs), standard operating procedures (SOPs), and clinical research documentation. I have also contributed to clinical quality assurance activities and study-related operational processes.
I currently work in clinical data management, bringing together my scientific background, research methodology expertise, and practical understanding of clinical study processes.
My professional interests lie at the intersection of scientific research, clinical research, data quality, and evidence-based decision-making.
My career combines experience in the pharmaceutical industry, scientific research, and university teaching, integrating data analysis, scientific and clinical documentation development, and research project management.
01
Syneos Health
Clinical Data Analyst
February 2026 – Present
Management and review of clinical study data, including quality control, identification and resolution of discrepancies, and data cleaning and reconciliation activities, in accordance with applicable protocols, procedures, and quality standards.
02
K&H Latam Consulting
Clinical Trial Assistant / Clinical Quality Support
2024 – February 2026
Development of protocols and clinical documentation, standard operating procedures (SOPs), and training materials. Participation in quality assurance, audit preparation, regulatory documentation, and operational support for clinical studies.
03
CONICET / University of Buenos Aires
Scientific Researcher
2010 – 2025
Development and coordination of research projects in food science and technology, applied microbiology, and functional materials. Experimental design, statistical analysis, scientific publications, interdisciplinary collaboration, and supervision of researchers in training.
My professional experience in clinical research spans scientific and medical writing, clinical data management, quality assurance, and clinical research operations.
I have contributed to clinical studies across oncology, endocrinology, dermatology, and rare diseases, collaborating with investigators, sponsors, CROs, and multidisciplinary research teams.
My background combines scientific expertise, clinical study documentation development, data quality management, and an understanding of Good Clinical Practice (GCP) and regulatory requirements.
01
Clinical & Scientific Writing
Independent development of clinical study protocols, informed consent and assent forms, case report forms (CRFs), study guides, standard operating procedures (SOPs), and regulatory documentation.
Scientific literature review, evidence evaluation, and preparation of technical and scientific materials.
02
Clinical Data Management
Clinical data review and quality control, including assessment of data accuracy, completeness, consistency, and protocol compliance.
Discrepancy management through query generation, follow-up, and resolution, supporting data cleaning, reconciliation, and study deliverables.
Currently working in Clinical Data Management at Syneos Health.
Professional certification
Certified Clinical Data Associate (CCDA)
Society for Clinical Data Management (SCDM)
Professional certification in clinical data management.
03
Quality Assurance & Compliance
Document quality control, version management, essential document review, audit preparation, and inspection readiness.
Experience with Investigator Site Files (ISF), Trial Master Files (TMF), pharmacy documentation, study logs, and quality checklists.
04
Clinical Research Operations
Support for study initiation, site readiness, regulatory and ethics documentation, and coordination with investigators, sponsors, CROs, and clinical research teams.
Experience supporting study documentation, investigational product management, and clinical research workflows.
05
SOP Development & Training
Development of standard operating procedures (SOPs) and operational workflows covering informed consent, patient pathways, investigational product management, adverse event reporting, and other clinical research processes.
Preparation and delivery of Good Clinical Practice (GCP) and SOP training for clinical research personnel.
04Scientific Research
Research in Food Science and Technology
For over 12 years, I developed my scientific career at CONICET and the University of Buenos Aires, specializing in food science and technology, applied microbiology, and the development of functional materials.
My research focused on the design, development, and characterization of edible films and coatings containing antimicrobial compounds, aimed at improving food preservation, quality, and safety.
My experience includes designing and conducting experimental studies, directing funded research projects, statistical data analysis, scientific publishing, and training researchers.
Research Areas
01
Edible Films and Coatings
Development and characterization of biodegradable and edible materials from biopolymers, with applications in food preservation and protection.
02
Antimicrobial Systems
Incorporation and evaluation of natural antimicrobial compounds and bioactive agents in polymer matrices, investigating their activity and potential to extend food shelf life.
03
Functional Material Characterization
Evaluation of the physicochemical, mechanical, barrier, and functional properties of edible films through experimental techniques and statistical analysis.
Funded Research Projects
PICT 2020 — ANPCyT
Development and characterization of edible films based on zein, ethanolic extracts, and natural antimicrobials for sliced cheese preservation
Period
2022–2024
Code
PICT-2020-SERIEA-02002
Funding organization
National Agency for the Promotion of Research, Technological Development and Innovation (ANPCyT)
Role
Director
A project focused on the development and characterization of edible films containing bioactive components and natural antimicrobials for use in sliced cheese preservation.
Development, optimization, and application of starch-based edible films containing bioactive compounds and natural antimicrobials for food preservation
Period
2023–2024
Code
UBACyT 20020220400141BA
Funding organization
University of Buenos Aires
Role
Director
A project focused on the development and optimization of starch-based edible films incorporating bioactive compounds and natural antimicrobials for use in food preservation systems.
My academic work included directing and supervising undergraduate and doctoral students, coordinating research activities, and collaborating with multidisciplinary teams.
I contributed to the training of one doctoral researcher and six undergraduate students, supporting experimental design, interpretation of results, and scientific communication.
Scientific Output
My research findings were disseminated through articles in international scientific journals, specialist book chapters, and presentations at national and international conferences.
I also served as a manuscript reviewer for international scientific journals.
A collaborative research project investigating edible films incorporating natamycin and nisin, published in Food and Bioprocess Technology.
Research Question
How can antimicrobial compounds be incorporated into edible films for potential applications in cheese packaging?
Approach
The study investigates active films containing natamycin and nisin, combining edible material development with food microbiology.
Scientific Relevance
Understanding the relationship between film composition, antimicrobial functionality, and material properties contributes to research on alternative food packaging technologies.
My scientific publications focus on edible films, antimicrobial packaging systems, and the physicochemical and functional properties of food-related materials.
My academic experience also includes scientific peer review, collaborative research, and the supervision of undergraduate and doctoral research projects.
I welcome opportunities for scientific collaboration, interdisciplinary projects, and professional connections in scientific research, clinical research, and clinical data management.
Whether exploring research collaborations or exchanging perspectives on scientific and clinical research, I value meaningful connections across academic and industry environments.