20 publicaciones de empleo destacadas de clinical scientist, clinical science, cronos en loreto cdmx (¡Están contratando!)

Start-up Specialist
Fortrea —Ciudad de México, CDMX
- Tiempo completo
- Bachillerato
- Licenciatura
- Capacitación
Senior Engineering Manager
SimplePractice —Ciudad de México, CDMX
- $1,659,280 a $2,074,100 por año
- Administración de personal
- Informática
- Maestría
- Seguro dental
- Seguro de la vista
Postulación rápida
Site Management Associate I
PSI CRO —Ciudad de México, CDMX
- Tiempo completo
- Trabajo híbrido
- Inglés
- Investigación
- Microsoft Office
Postulación rápida
Engagement Mgr, Technology Consulting
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Experiencia en ventas
- Inglés
Site Activation Manager (Global)
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Licenciatura
- Mejora continua
Senior Specialist, Sales, Advanced Patient Monitoring
Edwards Lifesciences —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Experiencia en ventas
- Mercadotecnia
6d
Digital Medical Sales Manager
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Powerpoint
- Microsoft Excel
- Experiencia en ventas
4d
Assoc. Site Activation Manager - Sponsor Dedicated
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Licenciatura
- Terminología médica
Technical Support Consultant (Data & Analytics)
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Informática
- SQL
- Licenciatura
Project Manager - Operations
Signant Health —Ciudad de México, CDMX
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Manager, COA Service Offerings & Quality
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Investigación
Managed Services Analyst
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Licenciatura
- Sin título de educación superior
Sr./ Concierge Corporate Travel Associate
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Disponible para viajar
SAP FICO Functional Consultant
Cognizant —Colonia Polanco, CDMX
- Tiempo completo
- Trabajo híbrido
- Administración de personal
- Mejora continua
Digital Health Enablement Manager
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Word
- Microsoft Excel
- Licenciatura
Senior Site Contracts Associate
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Licenciatura
- Contratos
Business System Analyst - Remote Job.
Bertoni Solutions —Ciudad de México, CDMX
- Tiempo completo
- Home Office (Desde casa)
- Azure
- Administración de personal
- DevOps
Postulación rápida
Sales Representative
Beckman Coulter Life Sciences —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Disponibilidad para viajar hasta un 50 %
- Experiencia en ventas
- Seguro dental
- Vacaciones adicionales o permisos con goce de sueldo
SENIOR SOLUTIONS ARCHITECT (LatAm)
TransPerfect —Ciudad de México, CDMX
- Tiempo completo
- Home Office (Desde casa)
- Microsoft Excel
- Administración de personal
- Experiencia en ventas
Postulación rápida
17h
(Senior) Data Team Lead
IQVIA —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Licenciatura
- Liderazgo

Quiero recibir la alerta de empleo más reciente para clinical scientist, clinical science, cronos en loreto cdmx

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Start-up Specialist

Fortrea -
Ciudad de México, CDMX

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Información del empleo

Tiempo completo

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

clinical scientist, clinical science, cronos empleos en loreto cdmx

Start-up Specialist

Senior Engineering Manager

Site Management Associate I

Engagement Mgr, Technology Consulting

Site Activation Manager (Global)

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Digital Medical Sales Manager

Assoc. Site Activation Manager - Sponsor Dedicated

Technical Support Consultant (Data & Analytics)

Project Manager - Operations

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Business System Analyst - Remote Job.

Sales Representative

SENIOR SOLUTIONS ARCHITECT (LatAm)

(Senior) Data Team Lead

Quiero recibir la alerta de empleo más reciente para clinical scientist, clinical science, cronos en loreto cdmx

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