María Rodríguez García
Avenida Paseo de la Reforma 505, Apartamento 12B
Mexico City, CDMX
+52 55 2847 3619
maria.rodriguez.garcia@email.com
https://www.linkedin.com/in/mariarodriguezgarcia

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Professional Experience

Senior Lead Clinical Data Manager
Pharmaquest Clinical Solutions - Mexico City, CDMX
January 2020 - Present
- Lead a team of clinical data managers in the execution of data management activities for multiple oncology clinical trials, ensuring compliance with Good Clinical Practice (GCP) and regulatory requirements.
- Oversee the design and implementation of electronic data capture systems, enhancing data quality and integrity through rigorous validation processes.
- Collaborate with cross-functional teams to develop and maintain clinical trial protocols, ensuring alignment with project timelines and objectives.
- Conduct training sessions for new team members on data management processes and tools, fostering a culture of continuous improvement and knowledge sharing.

Clinical Data Manager
BioResearch Analytics - Monterrey, Nuevo León
June 2016 - December 2019
- Managed data collection and validation processes for Phase I and II clinical trials in oncology, achieving a 95% data accuracy rate.
- Developed and maintained comprehensive documentation for data management activities, facilitating internal audits and regulatory inspections.
- Acted as a liaison between clinical operations and data management teams to ensure timely and efficient data flow throughout the trial lifecycle.

Clinical Research Associate
Clinical Trials Management Group - Guadalajara, Jalisco
March 2014 - May 2016
- Conducted site monitoring visits to ensure compliance with study protocols and regulatory requirements, contributing to successful trial outcomes.
- Assisted in the preparation of clinical study reports and publications, enhancing the visibility of research findings within the scientific community.
- Collaborated with investigators and site staff to facilitate data collection and resolve any issues related to data integrity and quality.

Research Assistant
Instituto de Investigación Médica - Mexico City, CDMX
January 2012 - February 2014
- Supported clinical research projects by performing data entry, management, and analysis, contributing to the successful completion of multiple studies.
- Engaged in the development of research protocols and informed consent documents, ensuring ethical standards were upheld throughout the research process.

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Education

Master of Science in Clinical Research
Universidad Nacional Autónoma de México - Mexico City, CDMX
Graduated: May 2011

Bachelor of Science in Biology
Instituto Tecnológico de Estudios Superiores de Monterrey - Monterrey, Nuevo León
Graduated: May 2009

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Skills

- Clinical Data Management
- Clinical Trials
- Data Quality and Validation
- Project Management
- Good Clinical Practice (GCP)
- Electronic Data Capture (EDC)
- Statistical Analysis System (SAS)
- Communication and Interpersonal Skills
- Leadership and Team Management
- Regulatory Compliance

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Publications

- Advances in Oncology Data Management: A Systematic Review, Journal of Clinical Research, 2019
- Improving Data Quality in Phase II Trials Through Automated Validation Systems, Clinical Trials Quarterly, 2018

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Certifications

- Certified Clinical Research Associate (CCRA)
- Good Clinical Practice (GCP) Certification

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Languages

- English (Fluent)
- Spanish (Native)
- French (Conversational)

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Hobbies

- Volunteering in health awareness programs
- Reading scientific literature on oncology and clinical research
- Participating in local running events