Clinical Trials Quality Assurance Auditor

hace 4 semanas


Ciudad de México, Ciudad de México PSI CRO A tiempo completo
Job Title: Clinical Trials Quality Assurance Auditor

We are seeking a highly skilled Clinical Trials Quality Assurance Auditor to join our team. As a key member of our international team, you will be responsible for ensuring high-quality standards within our clinical trials and internal company processes.

Your responsibilities will include:

  • Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits, and maintaining relevant communication with the auditee
  • Communicating with project teams regarding QA study audits, including follow-up and resolution
  • Assembling QA audits documentation
  • Training PSI Operations staff in quality management topics

Please note that this role requires international travel for site audits.

Qualifications:

  • MD, PharmD, or degree in life sciences is a plus
  • A minimum of 3 years' experience in quality management or quality assurance in a clinical study environment
  • Must have experience in planning, conducting, and reporting of QA audits
  • Excellent knowledge of ICH GCP guidelines, EMA, and FDA regulations, and applicable local laws/regulations
  • Team-oriented with superior communication and interpersonal skills, including a proactive attitude to tasks and projects
  • Excellent time management skills
  • Demonstrated ability to meet tight deadlines, multi-task, be flexible, and thrive in a fast-paced work environment
  • Full working proficiency in English
  • Proficiency in MS Office applications
  • Ability to travel

At PSI CRO, we focus on our people and invest in their professional development and success. Our recruitment process is easy and straightforward, and we'll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.



  • Ciudad de México, Ciudad de México PSI CRO A tiempo completo

    Job DescriptionWe are seeking a highly skilled Quality Assurance Auditor to join our team at PSI CRO. As a Quality Assurance Auditor, you will play a critical role in ensuring the high quality standards of our clinical trials and internal company processes.Your responsibilities will include:Conducting and reporting of QA study audits, internal systems and...


  • Ciudad de México, Ciudad de México PSI CRO A tiempo completo

    We are seeking a Quality Assurance Specialist to join our team at PSI CRO. As a Quality Assurance Specialist, you will be responsible for ensuring high quality standards within our clinical trials and internal company processes.Your key responsibilities will include:Preparing, conducting, and reporting of QA study audits, internal systems and location...


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

    Job Title: Quality Assurance AuditorWe are seeking a talented Quality Assurance Auditor to join our international team at PSI.Key Responsibilities:Plan, conduct, and report on quality assurance audits, including site audits and vendor qualification audits.Communicate with project teams to ensure smooth audit processes and resolve any issues that may...


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

    Job Title: Quality Assurance AuditorWe are seeking a skilled Quality Assurance Auditor to join our international team, working across multiple locations and time zones. As a Quality Assurance Auditor, you will be responsible for ensuring high quality standards within our clinical trials and internal company processes.Your Key Responsibilities:Preparing,...


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

    Job Title: Quality Assurance AuditorWe are seeking a highly skilled Quality Assurance Auditor to join our team at PSI. As a Quality Assurance Auditor, you will play a critical role in ensuring the high quality of our clinical trials and internal company processes.Your Key Responsibilities:Prepare, conduct, and report on QA study audits, internal systems, and...


  • Ciudad de México, Ciudad de México PSI CRO A tiempo completo

    We are seeking a Quality Assurance Auditor to join our international team, working across multiple locations and time zones. This role is home-based in Mexico.Your responsibilities will include:Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with...


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

    Job Title: Quality Assurance AuditorWe are seeking a highly skilled Quality Assurance Auditor to join our international team, working across multiple locations and time zones. As a Quality Assurance Auditor, you will play a critical role in ensuring high-quality standards within our clinical trials and internal company processes.About the Role:Conduct and...


  • Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

    About the RoleSyneos Health Clinical is seeking a highly skilled Clinical Trials Specialist to join our team. As a Clinical Trials Specialist, you will be responsible for ensuring the smooth conduct of clinical trials, from site qualification to close-out visits. You will work closely with project teams to ensure regulatory compliance and provide guidance to...


  • Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    About the RoleWe are seeking a skilled Clinical Research Specialist to join our team at Worldwide Clinical Trials. As a Clinical Research Specialist, you will be responsible for all aspects of assigned projects, including clinical assessment, training development, and data review.Key ResponsibilitiesAssist in the review of eCOA/ePRO specifications and engage...


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

    About the RoleWe are seeking a Senior Clinical Quality Assurance Specialist to join our team in Mexico. This is a home-based position, requiring international travel for site audits.Key ResponsibilitiesConduct quality assurance audits and assessments of clinical trials and internal processesCommunicate with project teams regarding audit results and...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Are you passionate about clinical trials and ensuring compliance with Mexican importation and exportation laws? We are looking for a Clinical Trials Senior Analyst to join our team at Novo Nordisk in Mexico.The PositionAs a Clinical Trials Senior Analyst, you will be responsible for:Ensuring compliance with importation and exportation laws, maintaining close...


  • Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo

    Job OverviewAs a key member of our team, you will be responsible for ensuring the smooth start-up and maintenance of clinical trials in assigned countries. This includes coordinating with investigative sites, collecting and organizing required documents, and interacting with regulatory authorities to ensure compliance with applicable regulations and...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Are you passionate about clinical trials and ensuring compliance with regulations? We are seeking a skilled Clinical Trials Senior Analyst to join our team at Novo Nordisk A/S in Mexico.The RoleAs a Clinical Trials Senior Analyst, you will be responsible for:Coordinating with importers, couriers, and customs agents to ensure compliance with importation and...


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

    Job OverviewWe are seeking a skilled and experienced Centralized Monitoring Lead to join our team at IQVIA. As a key member of our clinical trials operations team, you will be responsible for leading the centralized monitoring team and ensuring the successful delivery of clinical trials.Key ResponsibilitiesProject Oversight: You will oversee clinical...

  • Clinical Research Manager

    hace 3 semanas


    Ciudad de México, Ciudad de México MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo

    Job SummaryMEX Labcorp Clinical Development, S. de R.L. de C.V. is seeking a highly skilled Clinical Research Manager to lead our global clinical trials efforts. As a key member of our team, you will be responsible for managing clinical trials from feasibility to close-out, ensuring compliance with regulatory requirements and company standards.Key...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Are you passionate about clinical trials and ensuring compliance with Mexican importation and exportation laws? We are looking for a Clinical Trials Senior Analyst to join our team at Novo Nordisk. If that sounds like you, read on to learn more about this exciting opportunity.The PositionAs a Clinical Trials Senior Analyst, you will be responsible for...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Are you passionate about clinical trials and ensuring compliance with Mexican importation and exportation laws? We are looking for a Clinical Trials Senior Analyst to join our team at Novo Nordisk A/S in Mexico. If that sounds like you, read on to learn more about this exciting opportunity.The PositionAs a Clinical Trials Senior Analyst, you will be...


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

    Job OverviewWe are seeking an experienced Clinical Trials Project Manager to lead and oversee the execution of clinical projects and research studies in accordance with global and local regulations.Key Responsibilities:Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory requirements.Meeting quality & timeline metrics.Effective...


  • Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    **About the Role**Worldwide Clinical Trials is seeking a highly organized and detail-oriented Clinical Operations Specialist to join our team. As a Clinical Operations Specialist, you will be responsible for carrying out daily aspects of operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition,...


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

    Job OverviewAs a key member of our team, you will provide leadership and guidance to the centralized monitoring team, working closely with project and clinical leads to achieve project objectives. Your expertise will be instrumental in ensuring the delivery of high-quality clinical trials, while optimizing speed, quality, and cost. You will be responsible...