Clinical Process Coordinator

Clinical Process Coordinator, cFSP

Hybrid role (Mexico City)

Job Overview

Leads and oversees the execution of clinical projects and research studies

Provide project related assistance for all assigned project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, in accordance with global and local regulations to best meet customer needs while working toward organizational goals and strategies.

Provides project-related support to the project management teams of assigned clinical research studies. Establishes and maintains all project documentation; conducts technical reviews and audits of files for accuracy and completion; tracks key communications and documents; and maintains internal systems and databases.

Essential Functions:

Includes but not limited to:

• Support in ensuring compliance with contract, SOPs, GCPs, policies, and regulatory
• Support in meeting quality & timeline metrics
• Assist study manager/ study lead in effective management of eTMF and its Inspection Readiness
• Establishment and maintenance of 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.

The CPC works in partnership with the Study Lead and the Study Process lead (CL) providing support with project management activities to mitigate risk, control cost, manage project schedule, and ensure customer satisfaction related to assigned project/s.

Qualifications

• Bachelor's Degree Life sciences or other related field Req
• 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.
• Typically requires 0 - 2 years of prior relevant experience.
• 1 year of relevant clinical research experience with analytical/financial skills or relevant Project Management experience or equivalent combination of education, training, and experience.
• GCP Course will be highly valued
• Advanced English level
• Excellent Communication and interpersonal skills.
• Excellent Problem solving and Organization skills
• Attention to detail skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.