Job Overview
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, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.
Essential Functions
•Support Clinical Operations activities under the supervision of the Study Process Lead.
•Manage TMF/eTMF activities, including filing, reconciliation, QC, and document review.
•Upload and reconcile regulatory documentation in designated systems.
•Track study, site, subject, visit status, and key milestones in CTMS.
•Support study payment processes and financial/invoice reconciliations.
•Generate and maintain operational reports, trackers, and dashboards.
•Support Feasibility activities, including site identification, FQ creation, follow-up, and reporting.
•Perform key study reconciliations and reporting, including IMP reconciliation and PD Listings.
•Support study close-out activities and documentation completeness assessments.
•Provide day-to-day operational and administrative support, including document management, SharePoint organization, system access, and study-specific activities.
Qualifications
•Bachelor's degree completed preferably in Life Sciences, Healthcare, Pharmacy, Biology, Administration, or a related field.
•6 months - 1 Year of previous experience in Clinical Research, Clinical Operations, or the pharmaceutical industry is preferred. An Internship experience works.
•Knowledge of GCP and clinical research processes.
•Strong organizational skills and attention to detail.
•Ability to manage multiple tasks and priorities while meeting established timelines.
•Good written and verbal communication skills.
•Ability to work effectively within a cross-functional and multicultural environment.
•Good working knowledge of Microsoft Office, particularly Excel, PowerPoint, Outlook, Teams, and SharePoint.
•Ability to work with trackers, reports, documentation, and clinical systems.
•Strong focus on quality, compliance, and accurate documentation.
•English proficiency sufficient to communicate effectively in a global business environment.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
