Paloma Hidalgo
Madrid
Summary
Clinical research professional with experience in managing facility operations and regulatory compliance. Demonstrated ability in data capture procedures and action planning, ensuring accurate management of patient information and laboratory specimens. Exceptional organizational and communication skills facilitate the successful execution of various clinical trials. Committed to advancing research excellence through meticulous adherence to protocols.
Overview
18
18
years of professional experience
Work History
Clinical Research Associate
Life Length
Madrid
07.2022 - Current
- Responsible for overseeing the progress of clinical performance studies by ensuring timelines, and ensuring compliance with ICH-GCP and applicable regulations.
- Developed and maintained study timelines and budgets, resulting in on-time study completion within budget.
- Performed pre-study, closeout and interim visits to check on study activities.
- Negotiated budgets to supply study centers with sufficient materials.
- Developed and managed budgets for clinical trials according to study protocols.
- Supported quality control program by scheduling site assessment visits for project and conducting monitoring visits.
- Dissemination of research results: Experience in effective communication of scientific results to diverse audiences, including preparation of technical reports, dissemination articles and conference presentations. Ability to adapt language and format according to the target audience, ensuring clear and accurate understanding of the results.
Cell Culture Technician
Merck KGaA
Madrid
10.2021 - 06.2022
- Development of Cell Culture Processes: Optimized the proliferation of mammalian cell lines (CHO cells) engineered for the production of human growth hormone (hGH)
- Documented and ensured compliance with Good Manufacturing Practices (GMP) and FDA standards for injectable therapeutics
- Tested and calibrated instruments to ensure accuracy and reliability of data.
R&D Specialist Injectable Formulation for RNA Vaccines
ROVI Pharma Industrial Services
Madrid
05.2021 - 09.2021
- Developed scalable processes for the preparation of mRNA-LNP complexes using microfluidics and controlled mixing systems
- Conducted stability testing under various conditions (temperature, light, and humidity) to ensure long-term integrity and efficacy of mRNA-based injectable formulations
- Generated reports to track performance metrics of team members.
- Coordinated with other departments to ensure efficient workflow processes.
Biobank Technician & CTA
Projects funded by ISCIII at the MD Anderson Foundation Biobank
Madrid
11.2014 - 06.2021
- Responsible for a database of over 60,000 human sample entries including daily collection, processing, molecular diagnostics and sample retrieval
- Participation in corporate R&D projects, providing support in management documentation
- Kits produced for the collection and storage of research samples in refrigerated and deep-freeze environments
- Conducted research projects related to specific topics as assigned by supervisor.
- Provided support to end users related to data entry issues and queries.
- Monitored data integrity and confidentiality by observing strict regulations and procedures.
- Reviewed technical manuals and other documents related to product operation and maintenance requirements.
Biobank Technician & Junior Investigator
Projects funded by ISCIII at the Hospital Clínico San Carlos
Madrid
03.2007 - 10.2011
- Managed clinical projects, coordinating activities with multidisciplinary teams.
- Supported the development and management of databases, including data cleaning and preparation for analysis
- Managed and processed biological samples in a biobank environment, ensuring proper storage and handling according to protocols.
- Created process to capture, integrate, and maintain data supporting field information applications.
Education
MBA - Data Science
ThePowerMBA
Madrid06-2024
Master of Science - Life Sciences
TECH
Madrid, ES12-2023
Bachelor of Science - Life Sciences
Universidad Autónoma Madrid
Madrid02-2007
Skills
- Good Manufacturing Practices
- ICH guidelines
- Monitoring visits
- Clinical data management
- Good Clinical Practices
- SSPS, RStudio, Python
- ISO 20916
- GLP LIMS
- UV/Vis spectrophotometry and HPLC
- Ethics committee liaison
- Protocol adherence
- Clinical trial management
- Completing regulatory documents
- Research and development
- Statistical modeling
- Machine learning
- Statistical software
Accomplishments
- Successfully completed projects
- Development of solutions to address recruitment and retention challenges in research projects.
- Publications and presentation of research project communications in medical and research journals.
Languages
- English, Advanced
- Spanish, Native
Expertise Courses
- Genetics and Cell Biology Expertise - ATG Medical, 2022
- Course on European Cosmetics Regulations (Regulation 1223/2009), 2021
- Regulatory Affairs & Biostatistics applied to research - FENAC, 2018
Timeline
Clinical Research Associate
Life Length
07.2022 - Current
Cell Culture Technician
Merck KGaA
10.2021 - 06.2022
R&D Specialist Injectable Formulation for RNA Vaccines
ROVI Pharma Industrial Services
05.2021 - 09.2021
Biobank Technician & CTA
Projects funded by ISCIII at the MD Anderson Foundation Biobank
11.2014 - 06.2021
Biobank Technician & Junior Investigator
Projects funded by ISCIII at the Hospital Clínico San Carlos
03.2007 - 10.2011
MBA - Data Science
ThePowerMBA
Master of Science - Life Sciences
TECH
Bachelor of Science - Life Sciences
Universidad Autónoma Madrid
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