Local Study Associate Director

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b8d7d

To lead Local Study Teams (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor Procedural Documents, international guidelines such as ICH‐GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director may perform site monitoring as needed to support the flexible capacity model.
The Local Study Associate Director is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Main 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 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 to Regulatory Authority for the duration of the study, and in line with local regulations.
Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in Sponsor clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).
Ensures timely preparation of local Master CSA (including site budg

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b8d7d