Lucía Rodríguez Ruiz de Gauna
Resumen profesional
I am a dedicated professional committed to ensuring client satisfaction. I bring extensive experience and a solid understanding of the industry. Highly adaptable, I work effectively both independently and as part of a team, leading work teams with strength and empowering each team member to support their individual development plan.
Datos destacados
25
25
years of professional experience
24
24
years of post-secondary education
Experiencia
Local Clinical Operations Manager
Boehringer Ingelheim S.A.
11.2020 - 11.2025
- Clinical research professional with over 5 years of experience leading teams, resource planning, team oversight and support.
- Manage strategic operations in clinical trials in Argentina, Chile, Colombia and Peru.
- Proven expertise in regulatory compliance, ethical strategy, and process-tools optimization across South America (Argentina, Chile, Colombia and Peru).
- Skilled in stakeholder engagement, CRO oversight, and delivering high-quality results in Phases II–IV and expanded access programs.
- Responsible for developing the optimal ethical and regulatory strategy for each study, considering different parameters; participating countries, number, type, and location of research sites, previous experience with those sites, competitive studies in the country, and document release from the global team.
- Responsible for monitoring key performance metrics in Phase II, III, and IV clinical trials, as well as expanded access programs and analyzing them against the stablished KPI.
- Specialized in regulatory frameworks in Argentina, Chile, Colombia, and Peru, with proven expertise in process and tools optimization, proficiency in systems and strong engagement with regulatory agencies and pharmaceutical industry stakeholders.
- Experience in country and site feasibility in diverse therapeutic areas (oncology, CRM, inflammation, CNS, immunology, respiratory) with strong knowledge of the best research sites that align with the needs and parameters of clinical studies.
- Facilitate trial execution, feasibility evaluations, and strategic initiatives through clear and impactful communication with internal and external stakeholders.
- Interaction with cross-functional partners from Regulatory Affairs, Medical Affairs, Patient Safety and Pharmacovigilance, Finance, Legal.
- Active participation in pharmaceutical product chambers across different countries.
- Excellent interpersonal and team management skills.
- Cross-functional collaboration and relationship building.
- Proficient in quantitative analysis and informed decision-making.
- Strong focus on integrity, adherence to compliance, and achieving strategic objectives.
- Proficient in adaptive project leadership with strong communication and influencing capabilities.
- Comprehensive and current expertise in regulatory frameworks across multiple jurisdictions and ICH-GCP.
Clinical Operations Manager
PRAhs (Providing regulatory services in MSD)
08.2017 - 11.2020
- Perform tasks at country level associated with Regulatory, Start-up activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines
- Coordinate the clinical trial coordinator (CTC) of each trial to ensure regulatory package received by sites, trackers updated, documents archived
- Ensure accurate completion and maintenance of internal systems with project specific information
- Prepare and update Informed Consent Forms (ICF) according to local regulation and Ethics Committee requirements
- Deliver answer to health authority and ethics committee queries, analyzing clinical protocol, investigator brochure and other documents
Regulatory Affairs 3
PRAhs (Providing regulatory services to Clinical Operations ROPU SA Boehringer-Ingelheim)
12.2017 - 08.2020
Regulatory Affairs 2
PRAhs (Providing regulatory Services to Clinical Operations ROPU SA Boehringer-Ingelheim)
07.2015 - 12.2017
RSU Specialist 2
Quintiles Argentina S.A.
04.2014 - 07.2015
RSU Specialist 1
Quintiles Argentina S.A.
04.2011 - 04.2014
- Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
- Distribute completed documents to sites and internal project team members.
- Review, prepare and negotiate site contracts and budgets with Principal Investigators/Sites.
- Review and provide feedback to management on site performance metrics.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to project team leader, Sponsor and management on site performance metrics.
- Review, establish and agree on project planning and project timelines (including research sites and Ethics Committee).
- Ensure monitoring measures are in place and implement contingency plan as needed.
- Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
- Perform quality control of documents provided by sites.
- Review of drug product´s labeling texts in accordance to local regulation.
- May have direct contact with Sponsors on specific initiatives.
- May participate in feasibility and/or site identification activities.
Regulatory Affairs Associate
Quintiles Argentina S.A.
07.2008 - 04.2011
- Submissions to Regulatory Agencies, Ethics /Teaching Committees and Ministry of Justice, physical and electronic archiving.
- Safety reporting.
- Informed Consent Form, patient materials adaptation to local requirements and document management (customization) and translations.
- Report SAEs to Independent Ethic Committee and ANMAT and prepare six-monthly progress reports for each project.
- Experience in training the internal staff.
- Responsible of the minutes on Regulatory Meetings.
- Expert in local regulation (member of the team specialized in Mendoza Province Clinical Trial Regulation).
- Expert on Ministry of Justice regulation.
Regulatory Affairs Assistant
Laboratorios Raymos S.A.C.I.
06.2007 - 06.2008
- Preparation and review of Technical Dossiers for drug products manufactured in Argentina.
- Requests to MoH (INAME and ANMAT) regarding renewal.
- Cancellation and modifications of registered medicines.
- Review of drug product´s package insert and labeling texts.
Administrative Area
Laboratorios Raymos S.A.C.I.
04.2001 - 06.2007
- Responsible of billing area.
- Interaction with APMs.
- Interaction with customers.
- General administrative activities.
Formación
Instituto Superior de Ciencias Humanas y Sociales - Psychological Counseling
Instituto Superior de Ciencias Humanas y Sociales
01.2014 - 01.2016
Degree in Nutrition - undefined
Universidad de Buenos Aires
01.2003 - 01.2013
Bachelor - undefined
Hans Christian Andersen School
01.1987 - 01.1999
Enfatiza tus habilidades clave
- Interpersonal skills
- Team management
- Cross-functional collaboration
- Relationship building
- Quantitative analysis
- Informed decision-making
- Integrity
- Compliance
- Strategic objectives
- Adaptive project leadership
- Communication
- Influencing capabilities
- Regulatory frameworks
- ICH-GCP
Languages
Español
Idioma nativo
English
Avanzado
C1
Courses and Trainings
- 07/01/11, Clinical Research Training – Clínica Suizo Argentina
- 06/01/12, Barnett Accreditation - Fundamentals GCP EXAM for support staff
- 06/01/14, Barnett Accreditation - Fundamentals GCP EXAM for support staff
- 11/01/15, “Estado actual de la Investigación en la Provincia de Buenos Aires”, course attended
- 08/01/16, Monitoring in Clinical Research Studies (FEFyM), course attended
- 01/01/17, Curso de Perfeccionamiento Técnico Profesional en Counseling en Organizaciones
- 2025, Update in ICH E6 (R3)-GCP
Cronología
Local Clinical Operations Manager
Boehringer Ingelheim S.A.
11.2020 - 11.2025
Regulatory Affairs 3
PRAhs (Providing regulatory services to Clinical Operations ROPU SA Boehringer-Ingelheim)
12.2017 - 08.2020
Clinical Operations Manager
PRAhs (Providing regulatory services in MSD)
08.2017 - 11.2020
Regulatory Affairs 2
PRAhs (Providing regulatory Services to Clinical Operations ROPU SA Boehringer-Ingelheim)
07.2015 - 12.2017
RSU Specialist 2
Quintiles Argentina S.A.
04.2014 - 07.2015
Instituto Superior de Ciencias Humanas y Sociales - Psychological Counseling
Instituto Superior de Ciencias Humanas y Sociales
01.2014 - 01.2016
RSU Specialist 1
Quintiles Argentina S.A.
04.2011 - 04.2014
Regulatory Affairs Associate
Quintiles Argentina S.A.
07.2008 - 04.2011
Regulatory Affairs Assistant
Laboratorios Raymos S.A.C.I.
06.2007 - 06.2008
Degree in Nutrition - undefined
Universidad de Buenos Aires
01.2003 - 01.2013
Administrative Area
Laboratorios Raymos S.A.C.I.
04.2001 - 06.2007
Bachelor - undefined
Hans Christian Andersen School
01.1987 - 01.1999