20 publicaciones de empleo destacadas de compliance & ethics en ciudad de méxico (¡Están contratando!)

Lead Clinical Research Associate
PSI CRO —Ciudad de México, CDMX
- Tiempo completo
- Home Office (Desde casa)
- Inglés
- Microsoft Office
- Licenciatura
Postulación rápida
Contracts Manager, North America
Rockwell Automation —Ciudad de México, CDMX
- Tiempo completo
- Experiencia en ventas
- Inglés
- Licenciatura
- Vacaciones adicionales o permisos con goce de sueldo
Senior Regulatory Compliance Manager, Mexico
Airwallex —Ciudad de México, CDMX
- Tiempo completo
- Trabajo híbrido
- Salesforce
- Inglés
- Liderazgo
Compliance Analyst
PayJoy —Ciudad de México, CDMX
- Tiempo completo
- Inglés
- Licenciatura
- Servicios financieros
- Seguro dental
- Seguro de la vista
14d
Regulatory affairs specialist
Pierre Fabre —Legaria, CDMX
- Administración de personal
Senior Specialist, Strategy
Schneider Electric —Ciudad de México
- Tiempo completo
- Administración de personal
- Inglés
- Maestría
Principal, End Users and Strategic Customers Field Sales
Schneider Electric —Ciudad de México
- Tiempo completo
- Administración de personal
- Inglés
HCP Engagement Specialist - Contracting Specialist - Associate
PwC —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Licenciatura
Account Manager III - Chromatography and Mass Spectrometry
Thermo Fisher Scientific —Ampliación Nápoles, CDMX
- Tiempo completo
- Administración de personal
- Experiencia en ventas
- Inglés
Analista de Implementación III
ADP —Ciudad de México, CDMX
- Microsoft Powerpoint
- Microsoft Excel
- Inglés
Infrastructure Supervisor
Eaton —Xoco, CDMX
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Outlook
1d
Senior Engineer I, Quality Continuous Improvement
Schneider Electric —Ciudad de México
- Microsoft Excel
- Administración de personal
- Inglés
6d
Head of Investigations
Orbia —Ciudad de México, CDMX
- Trabajo híbrido
- Administración de personal
- Inglés
- Licenciatura
2d
Informed Consent Specialist II
ICON Plc —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Microsoft Office
- Licenciatura
- Seguro dental
- Seguro de la vista
1d
DD&T Digital Learning, Analyst
Takeda Pharmaceutical —Cuajimalpa, CDMX
- Tiempo completo
- Administración de personal
- Informática
- Inglés
- Seguro dental
- Seguro de la vista
Industrial Automation Business Development Manager - (Senior Manager, Local / Regional Product Management)
Schneider Electric —Ciudad de México
- Tiempo completo
- Administración de personal
- Inglés
- Licenciatura
Senior Technical Trainer I
Schneider Electric —Ciudad de México
- Tiempo completo
- Administración de personal
- Inglés
- Licenciatura
Senior Site Navigator
Fortrea —Ciudad de México, CDMX
- Tiempo completo
- Inglés
- Bachillerato
- Licenciatura
Engineer II, Digital Systems Technical Execution
Schneider Electric —Ciudad de México
- Inglés
Documentation Analyst for Global Markets Bank and PE
BNP Paribas —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Excel
- Inglés
- Mejora continua

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Lead Clinical Research Associate

PSI CRO -
Ciudad de México, CDMX

Postulación rápida

Información del empleo

Tiempo completo

Cualificaciones

Inglés
Microsoft Office
Licenciatura

Descripción completa del empleo

Company Description

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams.

This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality.

Responsibilities:

Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures.
Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
Ensures data integrity and compliance at a site level.
Collaborates with investigator/ site feasibility and identification process, as well as study startup.
Manages Monitors in the query resolution process, including Central Monitoring observations.
Coordinates safety information flow and protocol/process deviation reporting.
Performs clinical supplies management with vendors on a country and regional level.
Ensures study-specific and corporate tracking systems are updated in a timely manner.
Coordinates planning of supervised monitoring visits and conducts the visits.
Manages the project team in site contracting and payments.
Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
Oversees project team in CAPA development and implementation.
Coordinates project team in process deviations review, management and reporting.
Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
Delivers trainings and presentations at Investigator Meetings.
Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.
Experience monitoring sites in the US.
Experience with all types of monitoring visits in Phase II and/or III.
Strong experience in Oncology preferred.
Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred.
Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.
Full working proficiency in English.
Proficiency in MS Office applications.
Ability to plan, multitask and work in a dynamic team environment.
Excellent Communication, collaboration, and problem-solving skills.
Ability to travel.

Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.

Postulación rápida

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compliance & ethics empleos en ciudad de méxico

Lead Clinical Research Associate

Contracts Manager, North America

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Senior Specialist, Strategy

Principal, End Users and Strategic Customers Field Sales

HCP Engagement Specialist - Contracting Specialist - Associate

Account Manager III - Chromatography and Mass Spectrometry

Analista de Implementación III

Infrastructure Supervisor

Senior Engineer I, Quality Continuous Improvement

Head of Investigations

Informed Consent Specialist II

DD&T Digital Learning, Analyst

Industrial Automation Business Development Manager - (Senior Manager, Local / Regional Product Management)

Senior Technical Trainer I

Senior Site Navigator

Engineer II, Digital Systems Technical Execution

Documentation Analyst for Global Markets Bank and PE

Quiero recibir la alerta de empleo más reciente para compliance & ethics en ciudad de méxico

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