Job Description
**Responsibilities:**
+ Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
+ Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
+ Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with sponsor’s Procedural Documents, ICH-GCP and local regulations.
+ Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
+ Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
+ Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions ...
+ Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
+ Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
+ Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with sponsor’s Procedural Documents, ICH-GCP and local regulations.
+ Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
+ Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
+ Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions ...
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