Sanofi Hiring Clinical Trial Support Associate - Hyderabad

About the job

The Clinical Trial Support Associate (CTSA) assists the Clinical Operations Study Leader (COSL), Global Study Leader (GSL for EDCO), and the Clinical Operations Study Country Leader (COSCL) across the full lifecycle of clinical studies. The role involves managing a variety of study, country, and site level activities delegated by these leaders to help ensure smooth execution and delivery of clinical trials.

The CTSA maintains oversight of study activities and coordinates across different levels within a study to track overall progress. The position works closely with the COSL and GSL to prepare study plans and materials, highlight potential issues, identify risks, and monitor adherence to the study plan. Support is also provided to the COSCL for country or site specific activities to maintain compliance and operational efficiency.

The role contributes to financial management tasks including budget tracking and invoice approvals in coordination with study leaders. The CTSA interacts with site monitors when needed to maintain compliance at the site level and ensures that activities are conducted with appropriate documentation for regulatory review.

Key collaborators include the Clinical Trial Support Manager (CTSM), vendor managers, and other members of the study team. Oversight of CTSA activities is provided by the COSL, GSL, and COSCL depending on whether tasks relate to study or country level operations.

Main responsibilities

• Support study and site communication as well as documentation activities.
• Facilitate communication with study teams and sites by distributing protocol amendments and Investigator Brochure updates.
• Create and distribute study newsletters and mass communications such as newsletters or memos.
• Maintain essential documentation including ICF tracking logs, Patient Data Report distribution and tracking, equipment leasing coordination, insurance request management, site training tracking, and maintenance of contact lists.
• Assist study teams in completing study documentation and ensure records are properly stored and archived in the Trial Master File (TMF) and relevant SharePoint locations.
• Process study, investigator, and vendor payment requests, manage invoices, create and track purchase orders, and report payment status to study leaders and site monitors.
• Track budgets across study, country, and site levels while supporting vendor management activities within finance systems.
• Configure and maintain CTMS at study, country, and site levels, including site account creation and system access management.
• Monitor CTMS compliance, generate reports, and maintain system data quality.
• Support access management for tools and systems used during clinical trials.
• Conduct in process control checks at study, country, and site levels to support inspection readiness.
• Assist with audit and inspection preparation, help draft responses, and provide administrative support for pre approval inspection readiness.
• Prepare CSR appendices and assist with BIMO related administrative activities.

About you

• Bachelor's degree in life sciences, healthcare administration, or a related field, or equivalent experience.
• Experience in clinical operations or clinical study management is preferred.
• Basic understanding of clinical development processes, GCP and ICH guidelines, and regulations from agencies such as FDA and EMA.
• Ability to prepare meeting notes, emails, study documentation, and other internal or external communications in English.
• Strong organizational abilities with the capacity to manage multiple priorities and deadlines.
• Comfort adapting to new technologies, digital tools, and operational processes.
• Familiarity with CTMS platforms and financial management systems or the ability to learn them quickly.