Summary
Overview
Work History
Education
Skills
Certification
LANGUAGE
ADDITIONAL EXPERIENCE
Publications
Timeline
Generic

Juliana González Zabala

Sant Pere de Ribes

Summary

Doctor of Veterinary Medicine with over 7 years of specialized experience in oncology clinical trials, recognized for a dynamic and adaptable approach to clinical research operations. Proven success as a Senior CRA and currently serving as Lead Senior CRA, where I oversee the end-to-end coordination of clinical trial activities. I ensure rigorous compliance with ICH-GCP and regulatory standards while driving operational excellence and quality across all trial phases. My career is marked by deep expertise in site qualification, study initiation, recruitment oversight, audit readiness, and study close-out. I am proficient in managing key clinical trial systems (CTMS, eTMF, EDC, IXRS) and bring extensive experience in vendor coordination, ensuring data integrity and adherence to the highest quality benchmarks. As a strategic liaison between sponsors and investigative sites, I excel in communication management and problem-solving within complex clinical environments. My ability to foster collaboration and streamline processes has consistently resulted in the successful delivery of project milestones and alignment with broader organizational goals.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Senior CRA- Liaison & Site Management on behalf of MSD

ICON CRO
03.2024 - Current
  • Primary Point of Contact: Serve as the key liaison between MSD CRA teams and clinical sites, ensuring seamless communication and effective collaboration.
  • Communication & Coordination: Optimize information exchange, aligning timelines, deliverables, and expectations between MSD and the site.
  • Issue Resolution & Compliance Oversight: Identify, escalate, and resolve operational, compliance, and technical challenges while ensuring adherence to ICH-GCP, Sponsor SOPs, and regulatory standards.
  • Study Monitoring & Site Performance: Track site progress, ensure protocol adherence, and provide regular updates to stakeholders, maintaining study alignment.
  • Training & Mentorship: Support site personnel through training on MSD protocols, systems, and tools, guaranteeing correct implementation and compliance.
  • Investigational Product (IP) Management: Oversee drug storage conditions, inventory, and accountability, ensuring regulatory compliance.
  • Audit & Inspection Leadership: Lead and support site audits, ensuring adherence to quality and regulatory standards.
  • Documentation & Reporting: Maintain comprehensive records of site communications, decisions, and activities, ensuring transparency and compliance.
  • Operational Efficiency & Process Improvement: Drive study execution, optimize workflows, maintain recruitment goals.
  • Cross-Functional Collaboration: Work closely with internal teams, investigators, sponsors, IRBs, vendors, and regulatory authorities to facilitate successful clinical trials.

Lead CRA & Site Management on behalf of MSD

ICON CRO
12.2020 - 02.2024
  • Genitourinary Oncology (Bladder Cancer: MIBC & NMIBC)
  • Played a key role in the operational execution of multicenter clinical trials targeting muscle-invasive and non-muscle-invasive bladder cancer, ensuring scientific rigor and regulatory compliance across all phases of study conduct.
  • Acted as the primary liaison between sponsor and investigative sites, fostering strong site relationships to optimize recruitment timelines and protocol adherence in complex oncology settings.
  • Led site activation and monitoring strategies tailored to genitourinary oncology protocols, with a focus on early detection, treatment efficacy, and patient safety.
  • Ensured high-quality data collection and reporting by guiding sites through protocol nuances, managing deviations, and resolving queries in collaboration with cross-functional teams.
  • Supported biomarker-driven studies through coordination of sample logistics, imaging submissions, and central pathology reviews, contributing to translational research efforts.
  • Facilitated audit readiness and inspection preparedness by maintaining robust documentation and proactively addressing compliance risks.
  • Contributed to strategic planning and operational forecasting, aligning site performance with broader clinical development goals.

Lead CRA Site Management & Monitoring

IQVIA CRO
01.2017 - 11.2020
  • Conducted site visits throughout all study phases, including site selection, interim monitoring, pharmacy inspections, and site close-out visits—both independently and in collaboration with team members.
  • Ensured that clinical trials were executed in full compliance with study protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
  • Delivered protocol-specific and study-related training to assigned sites, establishing consistent communication channels to manage expectations and proactively address site-level issues.
  • Assessed the quality and integrity of site practices to ensure proper protocol execution and regulatory adherence; escalated deviations and quality concerns to the Clinical Lead and/or Line Manager.
  • Oversaw study progress by tracking regulatory submissions and approvals, patient recruitment and enrollment, case report form (CRF) completion and submission, and resolution of data queries.
  • Maintained accurate and timely documentation of site management activities, monitoring visit outcomes, and corrective action plans through detailed visit reports and study records.
  • Contributed to the follow-up and timely execution of the Clinical Operations Plan, supporting project milestones and deliverables.

Clinical Trial Assistant

IQVIA CRO
01.2017
  • Supporting the Project team to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials in I, II and III Phases.
  • Performing regulatory document review and approval, including site specific Informed Consents.
  • Ensuring trial related activities are in compliance with GCO SOPs.
  • Maintaining site level protocol information in Trial Management Systems (e.g. CTMS)
  • Working with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
  • Distributing, collecting, reviewing, tracking and archiving documents, agreements and training.

Animalia CRO - Laboratorios de Sanidad Animal
01.2016
  • Plan, coordinate, and initiate action necessary to carry out projects.
  • Support in operational feasibility to evaluate the viability of the test, complying with GLP and SOPs, the quality, reliability and authenticity of data collected during the study.
  • Knowledge in ISO17025, ISO9001.
  • Knowledge in international standards (GLP/ICH/EMA) and European Pharmacopoeia.
  • Design and write clinical animal research protocols.
  • Data review, document preparation, data interpretation.
  • Participation in the preparation of presentations to the EC.

Centre de Recerca en Sanitat Animal, CReSA – IRTA
01.2009 - 01.2015
  • Laboratory Quality, GMP, GLP, ISO17025, ISO9001.
  • Design protocols for ethical animal experiment and working management at BSL2 and BSL3.
  • Develop experimental studies with animal models (mouse, pig and chicken) for evaluation of a candidate vaccine against influenza A viruses.
  • Monitor trials and writing the final reports of experimental studies.
  • Lead and coordinate all phases of experiment.
  • Prepare and submit manuscripts.

Education

Doctorate degree - Medicine and Animal Health

Universitat Autònoma de Barcelona
01.2016

Master’s degree - Veterinary research

Universitat Autònoma de Barcelona
01.2009

Bachelor’s degree - Veterinary Medicine

Universidad de La Salle
01.2007

Skills

  • Clinical Site Management
  • Leadership and Coordination of Clinical Trials
  • Monitoring and Oversight of Clinical Studies
  • Regulatory Compliance (ICH-GCP, Local Regulations, SOPs)
  • Investigational Product Management
  • Problem-Solving and Issue Escalation
  • Operational Efficiency and Timeline Management
  • Data and Documentation Tracking
  • Audit and Inspection Leadership
  • Data Review and Quality Control
  • Participation in Feasibility Studies and Site Selection
  • Training and Mentoring of New CRAs
  • Stakeholder Communication and Relationship Management
  • Interdisciplinary Collaboration with Sponsors, IRBs, and Regulatory Authorities

Certification

Category C (senior scientist) for laboratory Animal Handling and Experimentation Accredited by the Departament d’agricultura, ramaderia I pesca, Catalonia Government

LANGUAGE

Spanish
Bilingual or Proficient (C2)
English
Upper intermediate (B2)
Catalan
Upper intermediate (B2)
Chinese (Mandarin)
Beginner (A1)

ADDITIONAL EXPERIENCE

  • Universidad del Rosario-Universidad de la Salle, (Bogotá-Colombia) 2007
  • Design and develop the protocol for disinfection of the embrionic eggs of larvae of Lucilia sericata.
  • Management and maintenance of the larvae of L. sericata for use in veterinary clinic.
  • Evaluate the use of the larvae of L. sericata in rabbit model.
  • Provide diagnostic and clinical care for a variety of animal species and technical guidance.
  • Prepare manuscripts for publication
  • Centro de Primatología Araguatos - Universidad de la Salle (Bogotá-Colombia) 2006
  • Design and development protocols of the handling and restraining in non-human primate for clinical and radiological diagnosis in field.

Publications

  • Júlia Vergara-Alert, Ana Moreno, Zabala JG, Kateri Bertran, Costa TP, Iván Cordón, Raquel Rivas, Natàlia Majó, Núria Busquets, Paolo Cordioli, Fernando Rodríguez, Ayub Darji: Exposure to a Low Pathogenic A/H7N2 Virus in Chickens Protects against Highly Pathogenic A/H7N1 Virus but Not against Subsequent Infection with A/H5N1. PLoS ONE 03/2013; 8(3). DOI:10.1371/journal.pone.0058692.
  • Stella Zevgiti, Juliana González Zabala, Ayub Darji, Ursula Dietrich, Eugenia Panou-Pomonis, Maria Sakarellos-Daitsiotis: Sialic acid and sialyl-lactose glyco-conjugates: Design, synthesis and binding assays to lectins and swine influenza H1N1 virus. Journal of Peptide Science 01/2012; 18(1):52-8. DOI:10.1002/psc.1415.
  • Mauricio Rey A, Adriana Castañeda A, Juliana González Z, Víctor Acero P, Alexandra Segura G, Felio Bello G: Evaluation of maggot therapy applied to four clinical cases of animals in Bogota (Colombia). Revista colombiana de entomología 12/2010; 36(2):254-259.
  • Mauricio Rey, Adriana Castañeda, Juliana González Z, Víctor Acero, Alexandra Segura, Cristina Zapata, María A. Gaona, Dora Ríos, Felio J. Bello: Evaluation of the Larval Therapy in the Healing Process of Infected Wounds with Pseudomonas Aeruginosa in Rabbits. Revista Ciencias de la Salud 05/2008; 6(2).

Timeline

Senior CRA- Liaison & Site Management on behalf of MSD

ICON CRO
03.2024 - Current

Lead CRA & Site Management on behalf of MSD

ICON CRO
12.2020 - 02.2024

Lead CRA Site Management & Monitoring

IQVIA CRO
01.2017 - 11.2020

Clinical Trial Assistant

IQVIA CRO
01.2017

Animalia CRO - Laboratorios de Sanidad Animal
01.2016

Centre de Recerca en Sanitat Animal, CReSA – IRTA
01.2009 - 01.2015

Master’s degree - Veterinary research

Universitat Autònoma de Barcelona

Bachelor’s degree - Veterinary Medicine

Universidad de La Salle

Doctorate degree - Medicine and Animal Health

Universitat Autònoma de Barcelona
Juliana González Zabala