20 publicaciones de empleo destacadas de maintenance specialist en ciudad de méxico, dif (¡Están contratando!)

Start-up Specialist
Fortrea —Ciudad de México, CDMX
- Tiempo completo
- Bachillerato
- Licenciatura
- Capacitación
3d
Sustainability & Climate Product Marketing Specialist, Americas
MSCI —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Mercadotecnia
- Licenciatura
- Permiso de maternidad y paternidad
Regional Pharmacovigilance Associate (Temporal)
MSD —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Mercadotecnia
- Disponible para viajar
3d
Sr. Project Associate-ideal opportunity for CTA or Project Specialist (Hybrid CDMX- Mexico)
Syneos - Clinical and Corporate - Prod —Ciudad de México, CDMX
- Tiempo completo
- Inglés
- Microsoft Office
- Licenciatura
Field Control Systems Specialist
Baker Hughes —Ciudad de México, CDMX
- Tiempo completo
- Inglés
- Licenciatura
- Disponible para viajar
Product Data Specialist - Marketing,
OSRAM S.A. de C.V., Naucalpan, Mexico —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Excel
- Administración de personal
- SQL
Postulación rápida
Director, Technology Product Management
BSA-JLL - LaSalle Partners, MEX —Federal, CDMX
- Tiempo completo
- Oracle
- Administración de personal
- Informática
Postulación rápida
Senior Web Marketing Specialist
Qualcomm —Ciudad de México, CDMX
- Administración de personal
- Doctorado
- Inglés
IT System Specialist
ETAP —Ciudad de México, CDMX
- $21,000 a $29,000 por mes
- Tiempo completo
- Microsoft Excel
- Administración de personal
- Habilidades de organización
Azure Specialist
McDonald's Corporation —Ciudad de México, CDMX
- Tiempo completo
- Trabajo híbrido
- Microsoft Access
- Azure
- DevOps
Postulación rápida
Product Operations Specialist (Backoffice)
FeverUp —Ciudad de México, CDMX
- Inglés
- Microsoft Office
- SQL
Postulación rápida
Specialist Logical Security
Thales —Granjas Esmeralda, CDMX
- Tiempo completo
- Microsoft Access
- Administración de personal
- Informática
Project Associate-ideal opportunity for CTA or Project Specialist (Hybrid, Ciudad de Mexico)
Syneos - Clinical and Corporate - Prod —Ciudad de México, CDMX
- Tiempo completo
- Inglés
- Microsoft Office
- Licenciatura
9d
Workforce Systems Specialist – Time & Attendance
Celanese International Corporation —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Licenciatura
Account Executive - Fuel & Fleet (Ejecutivo de Cuenta - Combustible y Flotas) - Mexico City
Clara —Ciudad de México, CDMX
- Administración de personal
- Experiencia en ventas
- Inglés
3d
Sr. Credit Specialist
Kids II Inc —Ciudad de México, CDMX
- Tiempo completo
- Bilingüe
- Microsoft Excel
- Inglés
SPECIALIST II, END USER COMPUTING
Qualfon —Juárez, CDMX
- Tiempo completo
Customer Specialist
Boldr —Ciudad de México, CDMX
- Tiempo completo
- Home Office (Desde casa)
- Microsoft Excel
- Servicio al cliente
- Salesforce
Postulación rápida
7h
Product Line Specialist
Cargill —Ciudad de México, CDMX
- Inglés
Sr. Specialist Business Planner (Innovasport)
Adidas —Ciudad de México, CDMX
- Tiempo completo
- Licenciatura

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Start-up Specialist

Fortrea -
Ciudad de México, CDMX

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Información del empleo

Tiempo completo
Hace 3 días

Cualificaciones

Bachillerato
Licenciatura
Capacitación

Descripción completa del empleo

Job Overview:

Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region. Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable.

Summary of Responsibilities:

Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.
Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.
Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
Perform a review of final submission documents as applicable.
Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards
Prevent and escalate study issues appropriately and in a timely fashion.
Perform other duties as assigned by management depending upon country and situational requirements with proper supervision [if applicable].
In Country specific tasks (Global):
Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision.
Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.
Participate in team and project meetings as applicable.
When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.
Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.
Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.
Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.
Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):
Assist in the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.
Performs all other duties as needed or assigned.

Qualifications (Minimum Required):

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered.

Experience (Minimum Required):

Minimum of 2 years of experience in clinical development or start-up/ regulatory process.
Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.

Physical Demands/Work Environment:

General Office Environment.

Learn more about our EEO & Accommodations request here .

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Refina tu búsqueda

maintenance specialist empleos en ciudad de méxico, dif

Start-up Specialist

Sustainability & Climate Product Marketing Specialist, Americas

Regional Pharmacovigilance Associate (Temporal)

Sr. Project Associate-ideal opportunity for CTA or Project Specialist (Hybrid CDMX- Mexico)

Field Control Systems Specialist

Product Data Specialist - Marketing,

Director, Technology Product Management

Senior Web Marketing Specialist

IT System Specialist

Azure Specialist

Product Operations Specialist (Backoffice)

Specialist Logical Security

Project Associate-ideal opportunity for CTA or Project Specialist (Hybrid, Ciudad de Mexico)

Workforce Systems Specialist – Time & Attendance

Account Executive - Fuel & Fleet (Ejecutivo de Cuenta - Combustible y Flotas) - Mexico City

Sr. Credit Specialist

SPECIALIST II, END USER COMPUTING

Customer Specialist

Product Line Specialist

Sr. Specialist Business Planner (Innovasport)

Quiero recibir la alerta de empleo más reciente para maintenance specialist en ciudad de méxico, dif

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