Site Engagement Lead at Sanofi

Key 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
• 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.

Local Collaborative site strategy:

• Manage local Collaborative site strategy implementing an engagement plan based on CSU country strategy.
• Lead the possible involvement of these sites in Sanofi Global initiatives.
• Be accountable for the delivery according to the mutual benefit agreement with the site.

OneSite Strategy:

• If applicable in the country, as per proper categorization, identify, in collaboration with local and global stakeholders (R&D, Medical Affairs) site candidates to be considered for OneSite through an internal LT committee. Once confirmed, contribute, with the concerned stakeholders, the creation and maintenance of this new true mutual partnership including but not limited to formal agreement, budget, mutual objectives, deliverables, governance, action plan, the who is who. Participate as an active member of the Sanofi transversal function, account management team, assuming the role of Account Manager if it is appropriate for the CSU to do so.
• Be accountable for the delivery of clinical trial activity according to the agreement with the OneSite.

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.)

Site Performance and Metrics:

• Evaluate metrics of all sites to determine appropriate level of site engagement.
• Actively review metrics with Onesite sites and mutually agree on actions, explore new approaches with sites to drive operational excellence in a changing environment.
• SEL is accountable for OneSite site and local Collaborative site performance in clinical trials, being accountable for OneSite/local Collaborative site performance across all studies at those sites.

Support the implementation of R&R plan at the local level:

• Working closely with other Sanofi stakeholders in early identification of potential study participants, e.g., through electronic health records (eHR) patient identification at sites by collaborating with site staff/IT.
• In alignment with the GIL (Global Innovation Leads) and LIL (Local Innovation Leads), facilitate innovation (digital/DCT etc.) initiatives and collection feedback on such topic.
• Develop and boost DE&I initiatives in alignment with the global governance and matching study specificities.

Site issue escalation and facilitation of additional communication:

• Support monitoring team in issue communication and resolution with sites to improve quality at Local Collaborative sites and/or OneSite. Acting as a main contact with Local Collaborative sites and/or OneSite in case of transversal issue.

Best practices and lessons learned:

• Act as the local liaison and subject matter expert for clinical trial optimization based on site feedback. As part of this subject matter expert role, collaborate proactively with all stakeholders and ensure the insights/best practices gained are communicated as well as lessons learned to reduce repeated operational complexities.

Challenge:

• Occasional difficulties with conflict management between sites and Sanofi to maintain strong and valuable relationship with them. Solution: Increase trust between Sanofi and sites overtime by engaging in transparent, regular communication.
• Challenge: Complexity of stakeholder management due to high number of internal and external contacts with whom the SEL must maintain relationship. Solution: Develop a deep understanding of the RACI and communication pathways to ensure efficiency and successful task completion.
• Challenge: Balancing the strengths and weaknesses of site performance (fast start up, low enrollment or vice versa). Solution: Present clear SWOT analysis of site collaboration, set expectations with site for study start up timelines and performance. Create a clear and tailored metrics improvement plan for the site.

Decision Making Authority:

• Propose country-level site strategy to CSU Country/Cluster Head
• Evaluation of new sites to be included in Collaborative sites strategy (and OneSite if applicable in the country) and making strong recommendations to adding sites or removing sites to the program
• Discuss engagement opportunities with sites and initiate steps according to the strategy
• Validate site list during early planning stages in collaboration with the CSU MDA and local Medical Affairs.

ABOUT YOU:

• Bachelor’s degree in life sciences or related fields + 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.
• Advanced Clinical Development Process skills: Understands the governance that guides SANOFI clinical development strategy.
• Advanced Problem-Solving skills: Applies critical thinking to strategize ways of solving a problem.
• Advanced Project Management Skills: Applies continuous improvement methodology/tools.
• Advanced Change Management skills: Reinforces the change by supporting others.
• Advanced Emotional Intelligence, strives to integrate emotional awareness, self-management and social skills in daily activities to manage relationships effectively.
• Advanced Interpersonal & Relationship Management skills: Influences, inspires and encourages people to think in a certain direction without force whilst acknowledging their opinions.
• Intermediate Risk Management Skills: Proactively measure & assess/map risk triggers (Risks-Probability-Impact): Threats & Opportunities
• Intermediate Medical / Scientific Background -TA / Disease knowledge skills: Disease understanding (disease itself, diagnosis, therapeutic options, competitive environment).
• Intermediate Data Analytics (& Digital) skills: Data driven strategy is a key element in their leadership and management tasks.
• Advanced Business Acumen (Business Sense): Acumen in Action: Functional Plan - strategic goals, short term and long-term planning. Priorities team needs to focus on to make an impact on business.