Sarah Guerabes

-Actively participated in site selection visits, working closely with the Medical Advisor and Medical Science Liaison (MSL) to evaluate investigator eligibility and align sites capabilities with trial objectives and target patient number.

- Maintained close collaboration with the Clinical Project Manager in drafting and reviewing regulatory documents for submission to major health authorities.

-Creation of SIV slides in collaboration with the Local Study Manager.

-Delivered training sessions and documents creation to new CRA recruits assigned to SANOFI projects, covering protocol specific procedures and sponsor expectations.

-Led meeting with the Sponsor to define, propose, and validate organizational improvements

• - Supervised and coordinated clinical trials in oncology (Phase I), neurology (Phase II/III), and rare diseases (Phase II/III), ensuring adherence to protocols and regulatory requirements.

• - Trained medical teams at clinical sites.

• - Train trainees, organize and lead team meetings to monitor project progress and implement strategies to optimize patient recruitment.

• - Close collaboration with the MSL/PPSM during on-site SIV and throughout the study (Roche industry)

• - Writing of monitoring visit reports in English.

• - Monitored patient visits and data collection procedures.

• - Worked closely with investigators and sponsors to ensure smooth study progression.

• - Analyzed and interpreted clinical data for progress report preparation.

• - Managed essential documents in compliance with GCP (Good Clinical Practice).

• - Actively contributes to the improvement and updating of procedure manuals

• - Identified in source documentation and reported Adverse Events (AE) and Serious Adverse Events (SAE)

- Main point of contact for investigating sites, for Phase I (First in Human) and Phase II (initiation, maintenance, and

closure), in the therapeutic areas of cancer, neurology and rare diseases.

- Budget review and invoice management