Clinical Trials Assistant, cFSP

Hybrid role

Job Overview

Leads and oversees the execution of clinical projects and research studies 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 CTA 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
• 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.
• 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

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