Ciudad de México, Mexico · Hybrid
Job Overview: Senior Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as requir…
Skills: Site Activation, Regulatory Compliance, ICH/GCP Guidelines, Site Management, Contract Negotiation
Ciudad de México, Mexico · Remote OK
Sr CTM and CTM - Mexico - Remote ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, …
Skills: Clinical Trial Management, Site Management, ICH-GCP Compliance, Stakeholder Management, Team Leadership
Ciudad de México, Mexico · On-site
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Ciudad de México, Mexico · On-site
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Ciudad de México, Mexico · On-site
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Ciudad de México, Mexico · Remote OK
CDMX ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, ag…
Skills: eTMF Management, Clinical Trial Documentation, Quality Oversight, Compliance Monitoring, SOP Deviations Management
Ciudad de México, Mexico · Remote OK
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Skills: Pharmacovigilance, Drug Safety, Adverse Event Processing, Regulatory Reporting, Data Collection
Ciudad de México, Mexico · Remote OK
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Ciudad de México, Mexico · On-site
Viatris Healthcare México S. de R.L. de C.V Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address…
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Ciudad de México, Mexico · On-site
$55k–$70k/mo
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Ciudad de México, Mexico · Hybrid
About IQVIA IQVIA is a global leader in advanced analytics, technology solutions, and life sciences consulting. We help healthcare stakeholders drive innovation and improve patient outcomes worldwide. By combining data, …
Skills: Market Access Strategy, Quantitative Analysis, Qualitative Analysis, Data Analysis, Excel Modeling
Ciudad de México, Mexico · Hybrid
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Ciudad de México, Mexico · Hybrid
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Johnson & Johnson MedTechCiudad de México, Mexico · Hybrid
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Ciudad de México, Mexico · Remote OK
Senior Production Artist - Homebased - Mexico ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven o…
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Ciudad de México, Mexico · Remote OK
100% remote role Job Overview The Medical Information Case Processor responsibilities include receiving and documenting incoming telephone calls or emails from investigative sites or other sources reporting Lifecycle Saf…
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AbbottCiudad de México, Mexico · On-site
Representante de ventas | Puebla (Tlaxcala) Acerca de Abbott Abbott es líder mundial en cuidado de la salud, que crea ciencia innovadora para mejorar la salud de las personas. Siempre estamos mirando hacia el futuro, ant…
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Ciudad de México, Mexico · On-site
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less in…
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Ciudad de México, Mexico · Remote OK
Grants Specialist - Payments (FSP - Sponsor Dedicated) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values…
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Ciudad de México, Mexico · Hybrid
Gracias por tu interés en unirte a Solventum. Solventum es una empresa nueva en el ámbito de salud, pero con una sólida experiencia en la resolución de desafíos que transforman vidas y fortalecen el trabajo de los profes…
Skills: Clinical Training, Orthodontics, Technical Guidance, Stakeholder Management, Market Intelligence
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Coordinates site-level activities during the start-up phase of clinical studies, serving as the primary contact for investigative sites. Ensures regulatory compliance, manages site activation milestones, and handles contract and budget negotiations.
Requires a university degree in life sciences or equivalent clinical research experience (3-5 years). Must possess thorough knowledge of ICH/GCP guidelines and be fluent in both English and the local official language.
Job Overview:
Senior Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Senior Site Navigator role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.
The Senior Site Navigator serves as local country expert in study start-up activities for a particular country or region. As senior team members, they perform work with limited oversight and their responsibilities include acting as a “knowledge resource,” mentoring /training junior colleagues if suitable. The Senior Site Navigator proactively anticipates and mitigates issues that could delay the study.
Summary of Responsibilities:
Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements, including collaboration with project leadership and local monitors to collaboratively achieve project milestones while also ensuring patient rights, wellbeing and safety are protected
Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources.
Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey
Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required to support site selection in line with sponsor, protocol, local and country regulations and requirements
Support customization and translation of informed consent forms and patient-facing materials.
Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation from Site outreach, submissions, greenlight and until site activation. Maintenance and ongoing awareness of site regulatory compliance, supporting annual IRB/Independent Ethics Committee (IEC) renewals, PI change-over, and document expirations will be performed as applicable in compliance with local requirements.
Actively participate in study team meetings to support study progress, develop and implement action plans for site level risks, underperforming sites, or issues impacting project milestones and escalate issues in a timely manner
Support the CRA team in preparing for site initiation visits (SIVs) by coordinating with vendors, supplies teams, and study leads to ensure timely distribution of clinical study supplies, accesses and documents per study team guidance.
Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies (if applicable), and Regulatory Authorities by collaborating with Global Regulatory Submissions Lead (GRSL).
Perform initial contract and budget negotiations with the sites, as well as amended where applicable
Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times.
Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines
Ensure Fortrea is audit ready by completing accurate, timely, and consistent system compliance on an ongoing basis
Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget
Perform Case Review Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations, Serious Adverse Event (SAE) reporting, and all other duties as needed or assigned throughout the course of the study.
Perform country and site ICF review/customization, per local requirements
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) or 3-5 years' work experience in clinical research, including a strong working knowledge of the ICH/GCP 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 5 years' work experience in clinical research, including a strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations will be considered.
Fluent in local official language and in English, both written and verbal.
Experience (Minimum Required):
A scientific degree and/ or clinical expertise is optimal for this role.
Minimum of 3+ years of experience in clinical development or start-up/ regulatory process.
Thorough knowledge of ICH/GCP, 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.
Effective communication with various stakeholders, including site staff, CRO personnel, and regulatory authorities.
Ability to manage multiple tasks and deadlines simultaneously, ensuring that all requirements are met in a timely manner.
Understanding of relevant regulations and guidelines related to clinical trials and research.
Ability to identify and resolve potential issues that may arise during the start-up process.
Ability to negotiate contracts and budgets effectively with research sites.
Employees will leverage their existing experience and skills to assume additional responsibilities within the broader role. These will be aligned with operational requirements and internal training, without altering the fundamental nature or classification of the position.
Physical Demands / Work Environment:
Remote-based work required with possible office presence depending on location
Travel requirements: Limited for training only
Learn more about our EEO & Accommodations request here.
Bringing life-changing benefits to patients faster
Fortrea (Nasdaq: FTRE) is a leading global clinical research organization (CRO) dedicated to providing innovative clinical development solutions to the life sciences industry. With over 30 years of clinical research experience, Fortrea has evolved from Covance and Labcorp into a pureplay CRO built for biotech, biopharma, medical device and diagnostic innovators. Fortrea collaborates with both emerging and established companies to deliver agile, fit-for-purpose full service (FSO), functional service (FSP) and hybrid solutions. Fortrea provides comprehensive Phase I-IV clinical trial management, clinical pharmacology, and consulting services, backed by deep experience in more than 20 therapeutic areas. Operating in approximately 100 countries, our diverse and talented team brings scientific rigor, operational excellence, and a strong investigator site network to every trial. By combining the best of our legacy experience with forward-thinking innovation, Fortrea brings predictability to clinical trial execution and helps transform aspirations into outcomes. Together, exceptional is possible. Learn more at Fortrea.com
Offices: Research Triangle Park, NC, US
There are currently 471 open healthcare positions in Ciudad de México, Mexico listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include ICON plc, Thermo Fisher Scientific, IQVIA, Boehringer Ingelheim, Johnson & Johnson Innovative Medicine, among others. Browse the listings above to see every active employer.
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