ESR Associate Specialist

Overview

The ESR Associate Specialist supports Externally Sponsored Research activities for the Specialty Care, Vaccines, and General Medicines Global Business Units. The role supports study lifecycle management, financial compliance, research governance, quality standards, ethical requirements, and scientific integrity.

What you'll do

• Support Fair Market Value (FMV) review and approval by evaluating compensation benchmarks for Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC).
• Review clinical research budgets proposed by external sponsors using the established FMV evaluation process and escalate discrepancies to ESR Managers.
• Review ESR requests in the ESR System to ensure required documentation and critical information are complete, accurate, and compliant with established standards.
• Coordinate with ESR Managers and stakeholders to support accurate and consistent FMV benchmark updates.
• Support lifecycle management of externally sponsored research studies in the ESR & FMV platform, including data accuracy and system maintenance.
• Support operational activities from initial proposal submission to study closeout, including SRC management, ESR performance tracking, supply management, contracting, regulatory documentation, cross-reference letters, transfer of value reporting, payment tracking, and overall ESR program reporting.
• Collaborate with team members and stakeholders to support project alignment, prioritization, and compliance with approved processes.
• Identify and recommend process improvements and participate in company initiatives to add value to the business.
• Support analysis of project objectives and deliverables to identify potential risks and efficiencies and assess whether resources, budgets, and timelines are realistic.
• Track project key performance indicators (KPIs), flag issues, and propose solutions to achieve the project plan.
• Identify and evaluate alternative solutions to resolve or mitigate risks and escalate issues to ESR Managers as appropriate.
• Contribute operational insights to support team strategy and decision-making.
• Ensure adherence to established standards and processes to support operational excellence and compliance.
• Serve as a key point of contact for FMV process-related queries and escalate complex matters to the ESR Manager as needed.
• Provide project management support for ESR study management activities.
• Perform ESR quality control (QC) activities to ensure data accuracy and compliance with established standards.
• Support ESR study management and data maintenance within the ESR system.
• Support ad-hoc activities as assigned.
• Work closely with stakeholders from various GBUs and Sanofi Business Operations Activity teams.

What you'll need

• 1 to 3 years of relevant experience in clinical trials or clinical operations.
• Familiarity with Medical Systems.
• A degree in Medical, Pharma, scientific, or a related Life science field, with substantial project management or clinical trials and drug development experience.
• Strong written and verbal communication skills.
• 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.
• MS Office, including Teams, SharePoint, Excel, Word, and Outlook.
• Project management tools such as Smartsheet and Power BI.
• Excellent knowledge of English, spoken and written.

Nice to have

• Medical programs knowledge.
• GxP knowledge.

Details

• Location: Hyderabad.
• The role is based in Hyderabad and supports activities across multiple countries and regions.