Cassia Testa

• Support to the clinical operations team at BeiGene, ensuring successful execution of clinical study components.

• Ensured compilation and quality of the electronic Trial Master File (eTMF) while adhering to best practices and championing compliance with ICH/GCP and local regulations.

• Supported selection and set up of vendors for outsourced activities in the region, leveraging knowledge of regional clinical trial operations.

• Supported global clinical studies ensuring compliance with quality standards and regulations.

• Oversaw trial-level data in CTMS and eTMF, while handling vendor management and contracts.

• Led day-to-day logistics, project planning, study execution, and effective communication.

• Administrative and logistical support for local and global clinical trials, enabling Trial and Site Managers to achieve project goals.

• Led cross-functional collaboration for global trials as a Global CTA, ensuring smooth execution and closure activities.

• Developed and revised essential study documents for ethics submissions and maintained accurate protocol information in trial management systems, including eTMF.

• Managed full lifecycle of translation projects for Clinical Research and Pharma clients, ensuring clear communication and meticulous project management.

• Organized regular client meetings to discuss project progress, budgets, and timelines, fostering strong relationships.

• Developed and presented project estimates and proposals for client approval, optimizing efficiency and consistency with translation memory tools.