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Site Engagement Lead

hace 1 mes


Gobernador Juan E Martínez Corrientes, Argentina Sanofi US A tiempo completo

**_Site Engagement Lead (SEL)_**
- _ Location: Buenos Aires - Argentina_
- _ Type of role: Permanent - Full time _
- _% Remote working and % of travel expected _

**_About the job_**

Ensure that the needs of appropriate investigational sites, to meet patient recruitment and DE&I targets, are considered locally during the early planning phase for Sanofi’s clinical trials. Plan country-level sites strategy by proactively aligning country site engagement activity with Sanofi’s Clinical Trial engagement strategy and current and upcoming clinical development programs. Actively engage with investigational sites in all stages of clinical trial development activities from protocol development through to study completion, and across multiple programs, thus contributing to accelerated and more efficient clinical development of Sanofi compounds through improved site performance (reduced timelines, increased number of patients enrolled and better quality of study delivery). Drive and oversee the engagement strategy of all investigational sites for the CSU, adapting the level of personal SEL engagement in accordance with the mutual benefit agreement of the Collaborative and OneSite strategies. Be accountable for the clinical trial delivery (across studies) and implementation on innovative digital solutions at the Collaborative and OneSites. Provide transversal collaboration by supporting early planning activities, optimizing clinical trial operations, improving site engagement, and anticipating upcoming studies through stronger communication between the sites and Sanofi, and contributing to effective patient recruitment and retention plans at local level. Proactively assess improvement opportunities for the site engagement strategy, understand project needs and propose solutions to accelerate clinical trial development activities and improve site performance. Foster relationships with sites, even in complex environments**_ _**

**Main responsibilities**:

- Country-level sites strategy Proactively plan country-level sites strategy with CSU Country/Cluster Head and Medical Advisor Team, based on emerging indications and studies in alignment with the CSU Early Planning Leads group and local Medical Affairs. Early mapping of sites’ capabilities at current and potential new sites, where possible, across programs/studies to identify gaps in the country portfolio and propose a site engagement strategy with associated KPIs, agreed with the CSU Head and in close collaboration with Medical Affairs. SEL together with CSU head/LT is responsible for understanding the clinical trial ecosystem/environment in the country, influencing and impacting on it for improved future clinical trial delivery, i.e. representing CSU in front of relevant institutions/associations and/or attending meetings that can be key to reshape the country strategy in alignment with Medical Affairs and key internal stakeholders, supporting innovation and digital transformation of our clinical trial sites.
- Build and maintain robust relationships with new and existing sites and Investigators In accordance with country level site strategy, prioritizing local Collaborative site and OneSite (if applicable in the country). Develop meaningful connections with relevant site stakeholders (investigators and team members, clinical research management, legal and finance departments, IT department etc.), to support transparent and productive interactions between sites and Sanofi (two-way communication) in collaboration with the appropriate local and global Sanofi stakeholders with ultimate goals of: - Driving Sanofi investigator and site advocacy in alignment with global plan to identify and develop future investigators. - Sites’ early engagement (Early site ID and capabilities mapping) and Sanofi Portfolio info sharing;
- Supporting robustness of protocol design, conduct of clinical studies and recruitment and retention strategies through External Operational Roundtable and other feedback mechanisms. - Improvement of site processes that influence clinical trial performance (regulatory and start-up activities, patient access, GCP compliance, support electronic health records (eHR) for patient identification and patient pre-screening purposes). Decreasing site and patient burden. - Leverage and boost Digital Innovation, DCT implementation, in collaboration with LIL - Develop DE&I initiatives, in collaboration with MDA. - Collate, prioritise and recommend solutions to country level site needs with reference to environment and competitors.
- Early site ID and capabilities mapping Exchange early planning information to assist CSU with early site ID scenarios ahead of study concept to reduce start-up timelines, support site-level enrollment forecasting and reach the study commitment. Work with MDA in performing a joint analysis starting from High level Competitive Intelligence Report (disease/compound CI), released by EOS (Early Operational Strategy) group. Map interes