Sr. Clinical Trials Assistant
hace 4 días
Sr Clinical Trials Assistant
Location: Mexico City - Hybrid role
Job Overview
Leads and oversees the execution of clinical projects and research studies in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.
Provides project-related support to the project management teams of assigned clinical research studies. Establishes and maintains all project documentation; conducts technical reviews and audits of files for accuracy and completion; tracks key communications and documents; and maintains internal systems and databases.
Essential Functions:
Includes but not limited to:
Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory Support in meeting quality & timeline metrics Assist study manager/ study lead in effective management of eTMF and its Inspection Readiness Establishment and maintenance of Study in Gilead's Global Clinical Trials Management System (GILDA) Weekly reports and updates, dashboard management Tracking the subject, site and visit status and milestones in CTMS/sCTMS. Assist the STUDY LEAD in preparing reports and trackers to track various metrics (electronic data capture report, action items, Protocol deviations etc) Perform access management for the study team Support the clinical project team by accurately updating and maintaining clinical systems within project timelines.The Sr CTA works in partnership with the Study Lead and the Study Process lead (CL) providing support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.
Qualifications
Bachelor's Degree Life sciences or other related field Req +2 years of prior relevant experience, including experience managing eTMF . 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience. Knowledge of clinical trials - knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws, regulations, and guidelines, towards clinical trial conduct. Advanced English level Excellent Communication and interpersonal skills. Excellent Problem solving and Organization skills Attention to detail skillsIQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
-
Mexico City Worldwide Clinical Trials A tiempo completoRequisition Number7914Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...
-
Instructional Designer
hace 3 semanas
Mexico City Worldwide Clinical Trials A tiempo completoRequisition Number7898Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...
-
Instructional Designer
hace 2 meses
Mexico City Worldwide Clinical Trials A tiempo completoRequisition Number7898Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...
-
Clinical Research Manager
hace 4 semanas
Mexico City MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoDescription As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With...
-
Clinical Research Manager
hace 3 semanas
Mexico City MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completoDescription As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With...
-
(Senior) Clinical Trials Regulatory Manager
hace 1 mes
Mexico City IQVIA A tiempo completoPURPOSE Manages complex regulatory projects and programs and supports more junior members of the team. RESPONSIBILITIES Acts as a Clinical Trials Regulatory Manager (CTRM) on complex clinical trial projects/programs and may act as a Regulatory Oversight for a key customer. May act as a Project Manager on stand-alone projects Ability to...
-
(Senior) Clinical Trials Regulatory Manager
hace 3 semanas
Mexico City IQVIA A tiempo completoPURPOSE Manages complex regulatory projects and programs and supports more junior members of the team. RESPONSIBILITIES Acts as a Clinical Trials Regulatory Manager (CTRM) on complex clinical trial projects/programs and may act as a Regulatory Oversight for a key customer. May act as a Project Manager on stand-alone projects Ability to...
-
Clinical Research Assistant
hace 1 día
Mexico City Covance Latinoamérica A tiempo completoCovance is growing again in Mexico! This is an exciting opportunity to join one of the fastest growing parts of our business! • Act as contact for project team and study sites. • Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client...
-
Mexico City Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoDescription For over 30 years, Gilead has been a leading innovator in the field of virology, having developed many of today’s leading medicines for treating and preventing HIV and viral hepatitis. More recently, Gilead has expanded its oncology portfolio, and seeks to become a leader in this critical disease area. In this role as Director,...
-
Director, Clinical Development Oncology – LATAM region
hace 3 semanas
Mexico City Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completoDescription For over 30 years, Gilead has been a leading innovator in the field of virology, having developed many of today’s leading medicines for treating and preventing HIV and viral hepatitis. More recently, Gilead has expanded its oncology portfolio, and seeks to become a leader in this critical disease area. In this role as Director,...
-
(Senior) Clinical Trial Manager
hace 1 mes
Mexico City IQVIA A tiempo completoClinical Trial Manager – Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon...
-
(Senior) Clinical Trial Manager
hace 3 semanas
Mexico City IQVIA A tiempo completoClinical Trial Manager – Sponsor Dedicated. Clinical Trial Manager provides for the regional/global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure regional/global clinical operations deliverables progress according to agree upon...
-
Mexico City Abbott A tiempo completoThe Opportunity The primary location for this position is for our corporate offices in Mexico City, but could be also based in Bogota. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on...
-
Mexico City Gilead Sciences A tiempo completoJob Description For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help...
-
Director, Clinical Development Oncology – LATAM region
hace 3 semanas
Mexico City Gilead Sciences A tiempo completoJob Description For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help...
-
Senior Specialist
hace 2 meses
Mexico City Fortrea A tiempo completoThe Clinical & Ancillary Supplies Services (CASS) Senior Specialist: Coordinate and oversee aspects of logistics related to Clinical and Ancillary Supplies services. Support these services to both internal and external clients. Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies Independently...
-
Senior Specialist
hace 3 semanas
Mexico City Fortrea A tiempo completoThe Clinical & Ancillary Supplies Services (CASS) Senior Specialist: Coordinate and oversee aspects of logistics related to Clinical and Ancillary Supplies services. Support these services to both internal and external clients. Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies Independently...
-
Sr. Scientist Clinical Research â Nutritional Division
hace 2 semanas
Mexico City Abbott Laboratories A tiempo completoSr. Scientist Clinical Research â Nutritional DivisionAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve peopleâs health. Weâre always looking towards the future, anticipating changes in medical science and technology.Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for...
-
Clinical Trial Associate
hace 1 día
Mexico City Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Clinical Trial Associate (CTA) to join our A-team (hybrid*/remote). As a Clinical Trial Associate at Allucent, you will be the...
-
Assistant CRA
hace 1 mes
Mexico City Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...
