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Quintiles and IMSHealth have merged together to form the new QuintilesIMS. Each wanting to bring something new to customers, we deliver integrated information and technology solutions to drive healthcare forward. QuintilesIMS has approximately 50,000 employees conducting operations in more than 100 countries, dedicated to helping our clients improve their cl...
Job description
Primary Functions
The Lead Clincal Analyst (LCA) partners with the Clinical Lead (CL) and local country Site Monitors in project execution. The LCA provides contralized support and contributes to site management for a variety of protocals, sites and therapeutic areas. LCA creates study specific operational plans, supports study start-up, manages resources requests, performs ongoing clinical risk assessment through data trending and analystics and proposes potential mitigating actions in a timely fashion, and manages Investigators payments. The LCA liaises with and mentors the Clinical Analyst Support (CAS) on trial.
Roles & Responsibilities
Study Start-Up
Support the CL to develop the Clinical Operations Plan (COP), and study-specific documents, which may include but are not limited to: The Monitoring Plan, SDV Plan, Study Reference Manual/Guidelines/Instructions, annotated Site visit report, annotated Recruitment Strategy Plan (RSP) and Site Recruitment Action Plan (SRAP), letter templates, scripts for remote monitoring visits and telephone contact report templates as applicable. The LCA also develops training material for SSV / SIV.
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