
Clinical Operations Specialist
2 days ago
Serving as the Single Point of Contact (SPOC) in assigned studies, you will ensure that investigative sites adhere to Standard Operation Procedures (SOPs), work instructions (WIs), and project timelines.
You will be responsible for performing Regulatory Start-up and Maintenance activities according to applicable regulations, SOPs, and WIs. This includes distributing completed documents to sites and internal project team members.
A critical aspect of this role is preparing site regulatory documents, reviewing them for completeness and accuracy, and negotiating site contracts and budgets with sites.
In addition, you will be responsible for ensuring accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
Your expertise will also be utilized to review and provide feedback to management on site performance metrics.
You will work closely with the RSU leads and Project team to establish project planning and project timelines, ensuring monitoring measures are in place and implementing contingency plans as needed.
Furthermore, you will inform team members of completion of regulatory and contractual documents for individual sites and track progress, approvals, and execution of documents, including contracts, regulatory, ethics, ICF, and IP release documents in line with project timelines.
This role requires providing local expertise to RSU leads and Project team during initial and ongoing project timelines planning and performing quality control on documents provided by sites.
You may have direct contact with Sponsor on specific initiatives and perform Site Selection Visits if a trained monitor. Additionally, you may participate in feasibility and/or site identification activities.
Company Overview: As a leading global provider of clinical research services, commercial insights, and healthcare intelligence, IQVIA creates intelligent connections to accelerate the development and commercialization of innovative medical treatments, ultimately improving patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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Clinical Operations Manager
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Fatih, Istanbul, Turkey IQVIA Argentina Full timeJob OverviewProject Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs, policies...
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