Senior Clinical Trial Coordinator

hace 4 semanas


Ciudad de México, Ciudad de México MSD A tiempo completo

Job Description

This position plays a key role in overseeing trial and site administration. Working closely with senior management, the individual is responsible for preparing, organizing, distributing, and archiving clinical documents. In addition, they provide vital support for clinical and non-clinical supply management, ensuring accurate tracking and reporting. Collaboration with local teams is crucial for meeting Site Ready dates and submitting necessary packages to regulatory bodies. The role involves close cooperation with various departments like COM, CRM, CRA, and finance for effective management of CTRAs and payments.

Secondary Language(s) Job Description:

Key responsibilities include, but are not limited to:

  • Trial and site administration:
    • Track essential documents and report Safety Reports
    • Collate and distribute study tools and documents
    • Update clinical trial databases and trackers
    • Manage clinical and non-clinical supply in coordination with other country roles
    • Oversee Labeling requirements and translation change requests

  • Document management:
    • Prepare, collate, distribute, and archive clinical documents
    • Assist with eTMF reconciliation
    • Update manuals and documents as necessary
    • Ensure proper destruction of clinical supplies
    • Prepare Investigator trial file binders
    • Obtain translations of documents

  • Regulatory and Site Start-Up responsibilities:
    • Provide forms/lists for site evaluation/validation and site start-up
    • Track study insurance certificates
    • Support preparation of submission packages for regulatory agencies
    • Publish study results as required

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date: 05/15/2024

A job posting remains active until 11:59:59PM on the day BEFORE the specified end date. Please ensure timely application prior to the job posting end date.

Requisition ID: R292325



  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThis role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs or CTC Manager, the person prepares, collates, distributes and archives clinical documents.The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...


  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThis role is responsible for comprehensive trial and site administration. Under the oversight of the Senior COM or COMs or CTC Manager, the person prepares, collates, distributes and archives clinical documents.The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...


  • Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...


  • Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.Essential Functions Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...


  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThis position is responsible for ensuring performance and compliance for assigned protocols in a specific country, adhering to ICH/GCP and country regulations, company policies, quality standards, and adverse event reporting requirements both internally and externally. Under the guidance of the Head COMs, the individual will oversee the...

  • Clinical Research Manager

    hace 4 semanas


    Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionOur Clinical Research and Pharmacovigilance team strives to advance global healthcare through groundbreaking research and innovation. By conducting clinical trials and surveillance, we guarantee the safety and effectiveness of our current and upcoming products, producing cutting-edge, secure, and effective medications.Essential Knowledge in...


  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionOur Clinical Research and Pharmacovigilance team strives to advance global healthcare through groundbreaking research and innovation. By conducting clinical trials and surveillance, we guarantee the safety and effectiveness of our current and upcoming products, producing cutting-edge, secure, and effective medications.Essential Knowledge in...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job DescriptionAt 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...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    Job DescriptionAt 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...


  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations,our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Acts...


  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and...


  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionThe role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations,our policies and procedures, quality standards and adverse event reporting requirements internally and externally.Acts...


  • Ciudad de México, Ciudad de México MSD A tiempo completo

    Job DescriptionWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.• Performs clinical study site...

  • 16264-Sr CRA 1

    hace 4 semanas


    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functions Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...

  • 16264-Sr CRA 1

    hace 1 semana


    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functions Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...


  • Ciudad de México, Ciudad de México Marriott Vacations Worldwide A tiempo completo

    Are you ready to grow your dream career while making others' vacation dreams come true? Marriott Vacations Worldwide is a world premier organization for Vacation Ownership with resorts at destinations around the globe. Join our team and help deliver unforgettable experiences that make vacation dreams come true.Generic Position SummaryAs a member of the...


  • Ciudad de México, Ciudad de México Marriott Vacations Worldwide A tiempo completo

    Are you ready to grow your dream career while making others' vacation dreams come true? Marriott Vacations Worldwide is a world premier organization for Vacation Ownership with resorts at destinations around the globe. Join our team and help deliver unforgettable experiences that make vacation dreams come true.Generic Position SummaryAs a member of the...

  • cra 2

    hace 2 meses


    Ciudad de México, Ciudad de México IQVIA A tiempo completo

    Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.Essential Functions Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with...


  • Ciudad de México, Ciudad de México JW Marriott Hotel Mexico City A tiempo completo

    Job Number Job Category Sales & MarketingLocation Mexico Regional Office, Ejercito Nacional No. 350 Suite 4C, Mexico City, MÉX, Mexico VIEW ON MAPSchedule Full-TimeLocated Remotely? YRelocation? NPosition Type Non-ManagementSocial Media Senior Coordinator (Shared Service)BASADO EN CANCUN Position Summary A Social Media Senior Coordinator is a hotel-facing...


  • Ciudad de México, Ciudad de México Marriott International A tiempo completo

    Job Number Job Category Sales & MarketingLocation Mexico Regional Office, Ejercito Nacional No. 350 Suite 4C, Mexico City, MÉX, Mexico VIEW ON MAP Schedule Full-TimeLocated Remotely? YRelocation? NPosition Type Non-ManagementSocial Media SENIOR Coordinator (Shared service) BASADO EN CANCUN Position Summary: A Social Media Senior Coordinator is a...