Sr Clinical Trial Manager

Há 5 dias


Brasília, Brasil Advanced Clinical Tempo inteiro
Freelance Clinical Trial Manager looking after LATAM

Oncology-focused Midsized Pharma Company

The role will focus on vendor management and site engagement in LATAM for the Phase III global clinical trial.

Summary

The Senior Clinical Trial Manager oversees clinical trial sites from start-up to close-out, ensuring compliance with the study protocol, ICH guidelines, Good Clinical Practices (GCP), and regulatory requirements. They collaborate with the Clinical Project Manager (CPM), CRO representatives, and vendors to manage clinical studies effectively. Additionally, they may supervise Clinical Trial Managers to ensure deliverables are met on time, within budget, and to quality standards.

Participate in the planning, implementing, and managing clinical trials in compliance with industry regulations and ICH-GCP. - Oversee CROs and clinical trial sites, ensuring timely delivery, meeting recruitment targets, and producing high-quality data.Track site visit metrics, data quality concerns, and protocol deviations; conduct oversight visits for compliance evaluation. - Assist in initiation visits to confirm site training and foster relationships among sponsors, CROs, and investigators.Review CRA monitoring reports to ensure protocol and operational compliance; escalate issues for resolution.Collaborate with teams for efficient study start-up, identifying risks and ensuring timelines are met.Act as a subject matter expert on assigned protocols and manage CRO/site during start-up activities, including contract negotiations and document collection.Could you provide direction to ensure consistency in Clinical Operations processes across trials and regions?Work cross-functionally with departments to meet study requirements and timelines.Contribute to developing and reviewing study-related documents and deliver trial-specific training.Monitor open action items and data trends, addressing issues with CROs to enhance study execution and efficiency.Develop and oversee patient recruitment and retention strategies, acting on any deviations from the plan.

Experience

Minimum of 5 years of clinical operational experience in biotechnology, pharmaceuticals, and/or CROs.Strong understanding of GCP, ICH, GDP, relevant CFRs; familiarity with MHRA, EMA, and international regulations is a plus.Experience with clinical trial site start-up and initiation.Proven ability to build and maintain relationships with clinical trial sites and Principal Investigators.Strong communication skills for coordinating activities with internal teams, sites, and vendors.Proactive in identifying project challenges and proposing corrective actions with minimal supervision.Capable of working independently and delivering high-level presentations.Knowledge and experience in oncology.Previous experience as a Clinical Research Associate (CRA).



  • brasília, Brasil Advanced Clinical Tempo inteiro

    Freelance Clinical Trial Manager looking after LATAMOncology-focused Midsized Pharma CompanyThe role will focus on vendor management and site engagement in LATAM for the Phase III global clinical trial.SummaryThe Senior Clinical Trial Manager oversees clinical trial sites from start-up to close-out, ensuring compliance with the study protocol, ICH...


  • Brasília, DF, Brasil Worldwide Clinical Trials Tempo inteiro

    **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...


  • Brasília, Brasil Cogstate Tempo inteiro

    We’re a cognitive science company on a mission to optimize the measurement of brain health to advance the development of new medicines and to enable earlier clinical insights in healthcare.That’s why we’re seeking a Portugese & English speaking Clinician, Consulting Psychologist, Clinical Trials to join our team of Cogstate Clinicians. Cogstate...


  • Brasília, Brasil Cogstate Tempo inteiro

    We’re a cognitive science company on a mission to optimize the measurement of brain health to advance the development of new medicines and to enable earlier clinical insights in healthcare.That’s why we’re seeking a Portugese & English speaking Clinician, Consulting Psychologist, Clinical Trials to join our team of Cogstate Clinicians. Cogstate...


  • brasília, Brasil Cogstate Tempo inteiro

    We’re a cognitive science company on a mission to optimize the measurement of brain health to advance the development of new medicines and to enable earlier clinical insights in healthcare.That’s why we’re seeking a Portugese & English speaking Clinician, Consulting Psychologist, Clinical Trials to join our team of Cogstate Clinicians. Cogstate...


  • Brasília, DF, Brasil Parexel Tempo inteiro

    Join Parexel’s team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do. **Job Title** Clinical Operations Specialist At Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life - changing medicines to patients. We are seeking...


  • Brasília, DF, Brasil Parexel Tempo inteiro

    **In Parexel we are looking for experienced CRA to make onsite monitoring visits in Brazil.** **Oncology experience is required.** **Your time here** At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure...


  • Brasília, Brasil Hobson Prior Tempo inteiro

    Hobson Prior is seeking a Clinical Research Coordinator for an oncology study in Porto Alegre, Brazil. This role involves supporting clinical research activities on-site for a 6-month project, working approximately 20 hours per week.Please note that to be considered for this role you must have the right to work in this location.Responsibilities: Assist in...

  • Team Lead, TMF Operations

    3 semanas atrás


    brasília, Brasil Worldwide Clinical Trials Tempo inteiro

    Who we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...

  • Team Lead, TMF Operations

    3 semanas atrás


    Brasília, Brasil Worldwide Clinical Trials Tempo inteiro

    Who we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...


  • Brasília, Distrito Federal, Brasil Alimentiv Inc Tempo inteiro

    Job Title: Clinical Operations LeadAlimentiv Inc is seeking a highly skilled Clinical Operations Lead to join our team. As a key member of our clinical operations team, you will be responsible for overseeing the clinical operations of a project within a defined regional/global level.Key Responsibilities:Provide oversight of project deliverables, assigned...


  • brasília, Brasil Areti Health Tempo inteiro

    Help build cutting-edge technology that saves lives!Hiring anywhere in Latin America.Areti Healthis a venture-funded Silicon Valley startup that dramatically boosts clinical trial patient recruitment usinggenerative AI. Our technology allows pharmaceutical, biotech, and medical device companies to bring their therapies to patients faster thereby saving...


  • Brasília, Brasil Areti Health Tempo inteiro

    Help build cutting-edge technology that saves lives!Hiring anywhere in Latin America.Areti Healthis a venture-funded Silicon Valley startup that dramatically boosts clinical trial patient recruitment usinggenerative AI. Our technology allows pharmaceutical, biotech, and medical device companies to bring their therapies to patients faster thereby saving...


  • Brasília, Brasil Areti Health Tempo inteiro

    Help build cutting-edge technology that saves lives! Hiring anywhere in Latin America.Areti Health is a venture-funded Silicon Valley startup that dramatically boosts clinical trial patient recruitment using generative AI. Our technology allows pharmaceutical, biotech, and medical device companies to bring their therapies to patients faster thereby saving...

  • Senior Global Case Manager,

    4 semanas atrás


    Brasília, Brasil Meet Tempo inteiro

    Senior Global Case Manager, (ICSR Case Processing)Title: Senior Specialist, Global ICSR Case Processing & QC Department: Global Patient Safety Overview: Seeking an experienced Senior Specialist in Global ICSR Case Processing & QC to independently manage the processing and quality control of individual case safety reports (ICSRs), ensuring regulatory...


  • Brasília, Brasil O&M Halyard Latinoamérica Tempo inteiro

    Position OverviewThe Advanced Wound Care Marketing Product Manager is responsible for developing and executing marketing strategies for advanced wound care products. This role requires a strong understanding of both the medical device industry and the specific needs of the wound care market, including products like dressings and wound healing technologies....


  • brasília, Brasil Areti Health Tempo inteiro

    Help build cutting-edge technology that saves lives!Hiring anywhere in Latin America.Areti Health is afast-growingSilicon Valleyhealthcare technologystartup that dramatically boosts clinical trial patient recruitment usinggenerative AI. Backed by leading venture capital firms, we are on a mission to transform clinical research through technology thatallows...


  • Brasília, Distrito Federal, Brasil Tbwa ChiatDay Inc Tempo inteiro

    Be a Hero for Rare Disease PatientsAt Ultragenyx, we believe that taking impactful action to care for patients and our people is always the right thing to do. Our vision is to lead the future of rare disease medicine by challenging the status quo and creating a new model that advances our field. We do this by following the science, applying a novel rapid...


  • Brasília, Brasil Areti Health Tempo inteiro

    Help build cutting-edge technology that saves lives!Hiring anywhere in Latin America.Areti Health is afast-growingSilicon Valleyhealthcare technologystartup that dramatically boosts clinical trial patient recruitment usinggenerative AI. Backed by leading venture capital firms, we are on a mission to transform clinical research through technology thatallows...


  • Brasília, Brasil Meet Tempo inteiro

    Title: Senior Specialist, Global ICSR Case Processing & QC Department: Global Patient SafetyOverview:Seeking an experienced Senior Specialist in Global ICSR Case Processing & QC to independently manage the processing and quality control of individual case safety reports (ICSRs), ensuring regulatory compliance and excellence in data accuracy,...