Site Engagement Lead (SEL)

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 interest and capabilities (indications, DCT, innovation/digital, e-HR, D&I etc.) of sites for early engagement strategy, EOR (External Operational Roundtable) and Operational Feasibility (OF).
• External Operational Roundtable (EOR) Collaborate with MDA in identifying expert trialist candidates for EOR, follow up with expert trialist e.g., assess interest, collect CV, W8, W9 form (US only), facilitate any communication with expert trialists and Global Team ensure CDA is in place and Appian updated, set up the contract at local level and overseeing payments.
• Operational Feasibility (OF) SEL’s level of involvement in the OF activities will be shaped matching the needs of the country supporting MDA: CSU head/LT will define clear responsibilities for MDA and SEL for the conduct of the OF at country level. MDA remains the main point of contact for GFL in conducting OF and responsible for the country feasibility confirmation. Promote the inclusion of patients that are truly representative of the targeted study population, in alignment with the local regulatory requirements. In reference to DE&I objectives, work with Sites for DE&I awareness and early identification of DE&I population. If applicable, include this analysis in the feasibility stage (with the R&R plan) to create a strong patient profile to help the sites target ideal candidates
• Supporting Site selection Process Support site selection activities in alignment with Start-up Strategy Manager or LSM, to accelerate site activation on the basis of the SEL knowledge /feasibility feedback of the sites and any specific agreement or specific document set up with sites (e.g. Master Clinical Trial Agreements, Mutual confidentiality disclosure agreement etc.).

About you

• Experience: + 6 years of experience in the pharmaceutical industry or clinical-related discipline (e.g. investigative site). At least three-year experience in clinical trial activities, site facing position (e.g. CRA) is preferred. Familiarity with medical terminology, general understanding of R&D process and previous exposure to GCPs/ICH is required.
• Skills: Advanced Interpersonal & Relationship Management skills, Intermediate Risk Management Skills, Intermediate Data Analytics (& Digital) skills, Advanced Business Acumen, Intermediate Develop People & Lead Teams.
• Education: Bachelor’s degree in life sciences or related fields
• Language: Fluency in English

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