ESR Associate Specialist

Main responsibilities:

The Sanofi Business operations ESR Associate Specialist plays a key operational role within the Externally Sponsored Research (ESR) function, supporting the Specialty Care, Vaccines, and General Medicines Global Business Units. The role is responsible for ensuring effective study lifecycle management, financial compliance, and research governance. By maintaining alignment with Sanofi??s quality standards, ethical requirements, and industry benchmarks, the position helps ensure that externally sponsored research is conducted efficiently, compliantly, and with scientific integrity.

• Supports Fair Market Value (FMV) review and approval by assisting in the evaluation of compensation benchmarks for Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC).
• Reviews clinical research budgets proposed by external sponsors using the established FMV evaluation process and escalates discrepancies to ESR Managers.
• Reviews ESR requests in ESR System to ensure all required documentation and critical information are complete, accurate, and compliant with established standards.
• Coordinates with ESR Managers and stakeholders to support FMV benchmark updates for accuracy and consistency.
• Supports ESR Managers in the lifecycle management of externally sponsored research studies in the ESR & FMV platform, including data accuracy and system maintenance.
• Assists in managing operational activities for ESRs from initial proposal submission to study closeout, including SRC management, tracking ESR performance, supply management, contracting, obtaining regulatory documentation, cross-reference letters, transfer of value reporting, payment tracking, and overall ESR program reporting.

Ad-hoc activities - Supports ad-hoc activities as assigned.

People: (1) Collaborates with team members and stakeholders to support project alignment, prioritization, and compliance with approved processes. (2) Supports team initiatives and objectives by identifying and recommending process improvements and participating in company initiatives to add value to the business.

Performance: (1) Supports routine analysis of project objectives and deliverables to help identify potential risks, efficiencies, and ensure resources, budgets, and timelines are realistic. (2) Tracks relevant project key performance indicators (KPIs) and proactively flags issues or proposes solutions to achieve the project plan. (3) Identifies and evaluates alternative solutions to resolve or mitigate risks and escalates issues to ESR Managers as appropriate. (4) Contributes operational insights to support team strategy and decision-making. (6) Supports operational excellence and compliance by ensuring adherence to established standards and processes.

Process: (1) Supports as a key point of contact for FMV process-related queries, escalating complex matters to the ESR Manager as needed. (2) Reviews ESR budgets to verify that total costs align with industry-practiced benchmarks. (3) Provides project management support for ESR study management activities. (4) Performs ESR quality control (QC) activities to ensure data accuracy and compliance with established standards. (6) Supports ESR study management and data maintenance within the ESR system.

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About you

• Experience: 1 to 3 years of relevant experience in clinical trials, clinical operations and should be familiar of Medical Systems; Having Medical programs knowledge and GxP knowledge is desirable
• Soft skills: Strong communication skills (written & verbal), innovative and creative thinking Ability to think strategically with a strong ability to execute and exceed stakeholder expectations and project goals. Ability to manage multiple projects simultaneously in a fast-paced, dynamic environment.
• Technical skills: MS Office (including Teams, SharePoint, Excel, Word, Outlook), project management tools such as Smartsheet, Power BI.
• Education: Degree in a Medical/Pharma/scientific or a related Life science degree, with substantial project management or clinical trials and drug development experience.
• Languages: Excellent knowledge of English language (spoken and written).