Job Overview
Provide project related assistance to assigned project teams. Ensure all work is conducted in accordance with standard operating procedures, policies, valuable clinical practices and applicable regulatory requirements. Meeting quality and timeline metrics.
Essential Functions
- Complete appropriate role-specific training to perform job duties.;
- Under supervision, provides study level administrative support to the clinical study management team (examples of such tasks include, but not limited to running system reports, preparing and distributing status reports, creating and maintaining study trackers, follow-up for outstanding issues, etc.).;
- Assist in updating and maintaining systems within project timelines/plans and driving tracking compliance in various systems to enable credible data for analysis.;
- Perform the activities as per the task list delegated by CMS leads.;
- Assist CMs in the preparation of i-site pack for their respective sites and countries for assigned studies, by pulling associated reports.;
- Perform centralized monitoring activities on assigned sites and evaluate their quality and integrity as per the protocol, SOPs respective regulation and guidelines.;
- Prepare i-site pack for respective sites and countries for assigned studies.;
- Interact with sites/CRA and follow-up of missing data, pending queries, SDV backlog, visit schedule, PD, etc.;
- Establish and maintain effective project/site communication.;
- Assist leads in maintenance of internal systems, databases, tracking tools and project plans.;
- Manage the operational insight of the assigned sites/studies and complete the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.).;
- Perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy (inclusion
📌 Centralized Site Associate (Thane)
🏢 Iqvia
📍 Thane