Clinical Trials Project Manager

hace 3 semanas

Ciudad de México, Ciudad de México IQVIA A tiempo completo
Job Title: Sr. Clinical Trials Assistant

Job Summary:

We are seeking a highly skilled Sr. Clinical Trials Assistant to join our team at IQVIA. As a key member of our clinical research operations team, you will be responsible for leading and overseeing the execution of clinical projects and research studies in accordance with global and local regulations.

Key Responsibilities:

  • Provide project-related support to project management teams of assigned clinical research studies.
  • Establish and maintain all project documentation, conduct technical reviews and audits of files for accuracy and completion, track key communications and documents, and maintain internal systems and databases.
  • Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory requirements.
  • Support in meeting quality and timeline metrics.
  • Assist study manager/study lead in effective management of eTMF and its Inspection Readiness.
  • Establish and maintain Study in Gilead's Global Clinical Trials Management System (GILDA).
  • Weekly reports and updates, dashboard management.
  • Tracking the subject, site, and visit status and milestones in CTMS/sCTMS.
  • Assist the study lead in preparing reports and trackers to track various metrics (electronic data capture report, action items, Protocol deviations, etc).
  • Perform access management for the study team.
  • Support the clinical project team by accurately updating and maintaining clinical systems within project timelines.

Qualifications:

  • Bachelor's Degree in Life Sciences or other related field.
  • +2 years of prior relevant experience, including experience managing eTMF.
  • 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience.
  • Knowledge of clinical trials, including knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements (i.e. International Conference on Harmonization (ICH), Good Clinical Practice (GCP), relevant local laws, regulations, and guidelines, towards clinical trial conduct).
  • Advanced English level.
  • Excellent Communication and interpersonal skills.
  • Excellent Problem-solving and Organization skills.
  • Attention to detail skills.

About IQVIA:

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.

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