- Responsible for the preparation and coordination of submissions to regulatory, ethics and other bodies;- Perform independent quality review of submission packages;- Perform timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system;- Responsible for the timely follow-up for queries made by EC/CA;- Responsible for the timely and accurate data entry of all relevant Study Start Up activities into the appropriate clinical trial management system in assigned countries Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA)and Ethics Committee (EC) submission information, and similar information for other related;- Develop and maintain effective relationships with local, regional and country authorities.

- Supports the timely preparation and execution of Confidentiality Disclosure Agreements (CDAs), Clinical Study Agreements (CSAs), associated Budgets and vendor agreements. - Support the CMS in tracking of CDAs, CSAs, Site Intelligence, KPIs / Metrics as required- Support the CMS in providing input into ongoing update of the Playbooks and Templates with legal- Communication of potential process improvements for the contracting processes, identified during the course of the job responsibilities

Monitoring and analysis of pharmaceutical spending using Farmavision.SAS and Farmaweb.SAS system (Compensation, extra-regional expenditure…)Refund’s administration for pharmaceutical assistance provided through franchised pharmacies: minor prosthetic, assistance for diabetic medical devices and dietetic related products.

Repayments related to the drugs distribution in PHT.Supplier management.Systems management of PA electronic invoicing – Workflow - DW Archive Web system.Management of stocks and drugs distribution in the area of competence.Purchasing management towards the Oracle ERP system.

▪ Creation of reports related to clinical activity; ▪ Controlling and analysis of the clinical activity and databases management▪ Management of evaluation performance and monitoring performance indicators.