Senior Clinical Project Coordinator
hace 7 horas
Salary: $80,000 - $110,000 per year
About the Role
We are seeking a highly skilled Senior Clinical Project Coordinator to join our team at IQVIA in Mexico City. As a key member of our clinical project team, you will play a crucial role in leading and overseeing the execution of clinical projects and research studies.
Key Responsibilities:
- Provide project-related support to the 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; maintain internal systems and databases.
- Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory requirements.
- 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.
Requirements:
- 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 - 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 Us
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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