Clinical Operations Management


Mexico

Owen Bryan

Director of clinical operations

Owen has wide experience in different research areas, such as basic research, patent registration and clinical research. From 2010 to date, he has worked as CRA, Lead CRA, Director of the Research Team and Quality Manager for different phase III clinical studies, mainly in Cardiology. Previously, he worked as a Clinical Chemist, Laboratorist, Industrial Property Specialist and participated in a project for the establishment of a vaccine production center.

In 2010 he joined the basic research team of Tecnologico de Monterrey. Months later, he began to work as a Clinical Research Associate at the same institution. To date. He is currently Quality Manager at Cohortias Mexico and teaches at the University of Monterrey. He has 6 publications among original and review articles, and is a member of the National System of Researchers of Mexico.

Owen graduated with a Bachelor in Clinical Chemistry and Biology from the University of Montemorelos, and holds a Master's Degree in Science in Molecular Biology and Genetic Engineering from the Universidad Autonoma de Nuevo Leon.

He obtained his PhD’s degree in 2015 in Sciences with a specialty in Molecular Biology and Genetic Engineering.


Erika Maldonado

Regulatory affairs Manager

Erika is a professional whose great attention to detail and organization capacity have allowed her to stand out in the Regulatory Affairs area in projects she has participated in.

She has worked in international studies and in national studies, as part of the Pharmaceutical Industry (CROs) and with Educational Institutions (AROs), in therapeutic areas such as Cardiology and Oncology. Since January 2017 she has been the Manager of Regulatory Affairs at Cohortias México.

Erika holds a Nursing degree from the Universidad Autonoma de Nuevo León. She has 12 years of experience in the field of Clinical Research. During these years, she has held various positions such as Clinical Research Associate, Project Manager and Regulatory Affairs Specialist.


Gabriela Rivera

project manager

Gabriela is convinced that Clinical Research is an interesting area, full of day-to-day challenges for those who are involved in it. She is very committed to doing Clinical Research under the highest National and International quality standards for the health of patients.

She graduated with a Bachelor in Science in Chemical Engineering at the Universidad Autónoma de Nuevo Leon in December 2005 with honors. She began his experience in Clinical Research in 2006 as a Study Coordinator for clinical trials phase II and III, coordinating for 4 years in different therapeutic areas. In 2010 she started as Clinical Research Associate, working for Glaxosmith Kline on 2 Phase III vaccine projects simultaneously.

In 2011, she joined the Tecnológico de Monterrey's Academic Research Organization as Clinical Monitor, where for 5 years she held different positions and responsibilities in the area of Clinical Operations, such as Lead CRA, Project Manager and Clinical Team Lead for Latin America. Currently and since January of 2017 she is the Clinical Team Lead for Mexico, Argentina and Colombia in Cohortias Mexico.


Jaime Hinojosa

Quality assurance manager

Jaime believes that working with passion and quality results in the success and continuity of the entire organization. Think that quality should be adopted as a philosophy and a model of doing business always focused on our customers.

He has extensive experience in the development, implementation and maintenance of quality management systems for the pharmaceutical industry, clinical research and health services.

He has worked as Quality Control and Quality Assurance in Authorized Third Parties for the realization of drug interchangeability studies and as Quality Management Manager for clinical research sites.

Jaime has a degree in Clinical Chemistry Biologist from the Faculty of Medicine of the Autonomous University of Nuevo Leon, he has a Master's Degree in Quality Systems Administration from the Research Institute in Quality Processes. During his professional life, he has held various positions such as Quality Control Specialist, Quality and Training Manager, Quality Assurance Manager and Manager of Quality Management and Regulatory Affairs.


Colombia

Carolina Jimenez

Operational Team

Carolina is a professional in Bacteriology and Clinical Laboratory of the University College of Cundinamarca (2006), later in 2012, she specialized in Auditing and Quality Assurance in Health of the University EAN-School of Business Administration. He has a professional experience of around 13 years in quality assurance, regulatory affairs, pharmacovigilance, reactive surveillance, techosurveillance, blood bank clinical research with medicines, medical devices and in vitro diagnostic reagents in its different phases (I-IV- Post-marketing).

Since 2011 she is dedicated exclusively to his passion in clinical research with medical devices, at work level, to the health authority-INVIMA, to pharmaceutical laboratories, to the Clinical Research Organization (CRO) and to the Organization of site management (SMO), performing in positions with responsibilities and monitoring and control activities; independent consultant, clinical studies coordinator, clinical studies assistant (CTA), monitor (CRA and CRA freelance), specialist in regulatory matters and start-up activities with Ethics Committees (SSu and RA Specialist), contract and budget manager and supervision and the coordination of import licenses for the development of clinical studies.

Currently she’s proud to belong to a prestigious company such as Cohortias, which applies academy, high quality standards and an excellent business vision into Clinical Research, allowing me to develop the role of Clinical Studies Monitor (CRA) and Specialist in Regulatory Affairs in Colombia.