Clinical Trials Manager Position

Há 5 horas

Rio de Janeiro, Brasil beBeeClinicalResearchAssociate Tempo inteiro

Clinical Research Associate Job Description Job Summary: We are seeking a detail-oriented and experienced Clinical Research Associate to monitor and manage Phase 2 clinical trials. The successful candidate will ensure the trial is conducted in compliance with regulatory standards, Good Clinical Practice (GCP), and the study protocol. This role involves collaborating with investigators, site personnel, and cross-functional teams to ensure the safety and well-being of participants in early-phase clinical trials. Key Responsibilities: Site Management and Monitoring: Conduct site qualification, initiation, interim monitoring, and close-out visits. Ensure proper site adherence to protocols, GCP, and regulatory requirements. Verify and ensure accurate data collection and reporting. Assess site performance and provide corrective actions if necessary. Regulatory Compliance: Ensure all clinical trial documentation is maintained according to regulatory guidelines. Review informed consent documents and confirm proper consenting procedures. Collaborate with regulatory teams to ensure timely submissions and approvals. Safety and Data Management: Monitor and report adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities. Validate source data and resolve data discrepancies. Ensure timely and accurate documentation of clinical trial data in electronic data capture (EDC) systems. Collaboration and Communication: Build and maintain relationships with study investigators and site staff. Communicate study updates and findings to study sponsors and internal teams. Provide training to site personnel on study protocols, procedures, and GCP compliance. Qualifications: Bachelor's degree in Life Sciences, Nursing, or a related field. At least 2-4 years of experience as a Clinical Research Associate in oncology trials, with preference for Phase 2 experience. Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and ICH guidelines. Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS). Excellent organizational, problem-solving, and communication skills. Preferred Qualifications: Previous experience in early-phase oncology trials (e.g., dose escalation studies, first-in-human trials). Strong understanding of pharmacokinetics (PK) and pharmacodynamics (PD) assessments. Certification as a Clinical Research Professional (CCRA) is a plus.

  • Clinical Trials Manager Position

    Há 19 horas

    Rio de Janeiro, RJ, Brasil beBeeClinicalResearchAssociate Tempo inteiro

    Clinical Research Associate Job Description Job Summary: We are seeking a detail-oriented and experienced Clinical Research Associate to monitor and manage Phase 2 clinical trials. The successful candidate will ensure the trial is conducted in compliance with regulatory standards, Good Clinical Practice (GCP), and the study protocol. This role involves...

  • Senior Research Associate

    Há 2 dias

    Rio de Janeiro, RJ, Brasil beBeeClinical Tempo inteiro

    Medical Research Associate Position Our organization is seeking a detail-oriented and experienced Medical Research Associate to monitor and manage early-phase clinical trials. The selected candidate will be responsible for ensuring that the trial is conducted in compliance with regulatory standards, Good Clinical Practice (GCP), and the study protocol. This...

  • Hematology/oncology Account Manager, Brazil

    2 semanas atrás

    Rio de Janeiro, Brasil Massive Bio, Inc. Tempo inteiro

    **Hematology/Oncology Account Manager** Massive Bio is a rapidly growing health-tech startup founded in 2015 to provide every cancer patient with access to clinical trials regardless of location or financial situation. Our proprietary patient recruitment and enrollment enablement solution for oncology clinical trials solves every friction point in...

  • Clinical Logistics/supply Assistant

    Há 2 dias

    Rio de Janeiro, Brasil Servier Tempo inteiro

    **Date posted**:Nov 1, 2024**City**:Rio de Janeiro**Country/Region**:BR**Type of Contract**:Local Assignement**Job Requisition ID**:7330Clinical Logistics/Supply Assistant - .- Transform your future with a career in one of the largest multinationals in the pharmaceutical sector!- At our company, we believe that success starts with **taking care of **people...

  • Clinical Research Specialist

    2 semanas atrás

    Rio de Janeiro, Brasil beBeeClinicalResearch Tempo inteiro

    Clinical Research Associate Job Description This role plays a pivotal part in designing and analyzing clinical trials, interpreting complex medical data, and advancing innovative treatments and therapies. Onsite and remote monitoring activities are completed in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes. The...

  • Freelance Clinical Research Associate

    2 semanas atrás

    Rio de Janeiro, Brasil IQVIA Tempo inteiro

    Join IQVIA Biotech as a Freelance CRA supporting Phase 2 and 3 clinical trials. You'll lead site visits, monitor compliance, and ensure high-quality data—all while working with a passionate team.We currently have two projects in Brazil: Location: Brazil - travel required for both roles across Brazil Hours: 1 x 0.35 FTE and 1 x 0.6 FTE Start: ASAP Duration:...

  • Senior Clinical Data Science Programmer

    Há 7 dias

    Santana de Parnaíba, Brasil ICON Strategic Solutions Tempo inteiro

    Senior Clinical Data Science Programmer - Remote - Brazil ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior...

  • Principal Clinical Data Scientist

    Há 5 horas

    Rio de Janeiro, Brasil beBeeClinicalDataScience Tempo inteiro

    Job Description: This is a key role in the development and implementation of programming solutions to support the analysis and reporting of clinical trial data. The ideal candidate will have a strong background in computer science or a related field, with extensive experience in programming languages such as SAS, R, or Python.

  • Clin Trial Assist Gicors Be

    1 semana atrás

    Rio de Janeiro, Brasil PPD Tempo inteiro

    **JOB DESCRIPTION**: - We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of...

  • Principal Clinical Data Scientist

    Há 23 horas

    Rio de Janeiro, RJ, Brasil beBeeClinicalDataScience Tempo inteiro

    Job Description: This is a key role in the development and implementation of programming solutions to support the analysis and reporting of clinical trial data. The ideal candidate will have a strong background in computer science or a related field, with extensive experience in programming languages such as SAS, R, or Python.