R&D Clinical Trial Support Associate (Sanofi)

Roles and Responsibilities

Main responsibilities include:

• Ensure Study and Site communication and documentation tasks

• Facilitate site and study team communication by distributing protocol amendments and Investigator Brochure updates.

• Develop and disseminate study newsletters and mass site communications (newsletters, memos).

• Maintain documentation tasks including ICF tracking logs, Patient Data Report (PDR) distribution and tracking, equipment leasing coordination, insurance request management, site training tracking, and who's who list maintenance

• Supports completion of all study documents with the various study team members

• Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant Sharepoint locations as required.

• Ensure Financial management tasks

• Process study, investigator and vendor payment requests, manage invoices, create and track purchase orders (POs), and report payment statuses to COSL/GSL/COSCL and site monitor.

• Track budgets at study, country, and site levels, ensuring accurate payment status reporting and effective vendor management in finance systems

• Ensure CTMS & Systems Administration tasks

• Set up CTMS at study, country, and site levels, create and maintain site accounts, manage system access and manage tool access requests, for phase 1 studies maintain CTMS updated if applicable

• Monitor CTMS compliance, generate and distribute reports, and oversee system data quality.

• Support access management for any tool/system used for the clinical trial

• Audit and inspection administrative activities

• Conduct IPC (In-Process Control) checks at study, country, and site levels, support inspection readiness

• Assist with audit/inspection preparation and contribute to elaborate proper responses to audit/inspections, and provide PAI (Pre-Approval Inspection) readiness admin support.

• Prepare CSR appendices, manage BIMO activities,

About you

• Bachelor's degree in life sciences, healthcare administration, or related field or equivalent experience

• Experience in clinical operations and managing clinical studies is preferred.

• Basic knowledge of clinical development, GCP & ICH guidelines, regulations by major regulatory bodies such as FDA (Food and Drug Administration) and EMA (European Medicines Agency), and SOPs/ QDs.

• Strong written and verbal communication skills. English language skill: ability to exchange fluently write meeting minutes/ emails/ study documents, internal & external communications.

• Good organizational skills: ability to multi-task, skill in establishing priorities and meeting deadlines

• Readily adapt to new environment, technologies and processes (e.g. new digital tools)

• Proficiency in CTMS and financial management experience or ability to quickly learn new systems and processes.