Ziane Elaib

• Global precision oncology research program (GMB, SCLC, PDAC) survivors

• Oversee multiple oncology sites across Europe, Latin America, North Africa, and the Middle East.

• Conduct site initiation visits and train site staff on study procedures and samples management.

• Perform monitoring visits (on-site and remote) to ensure accurate data collection, Source Data Verification (SDV), and compliance with GCP and protocol requirements.

• Follow up on biospecimen collection and declaration (FFPE blocks, Sides, Surgery ) ensuring timely shipment and adherence to study timelines.

• Facilitate smooth onboarding and knowledge transfer during CRA handovers.

Ziane Elaib is a Senior CRA with expertise in managing and monitoring clinical trials. He is responsible for preparing and conducting SQV, SIV, IMV and COV in accordance with the CMP. He ensures the validity, accuracy, and completeness of clinical data collected, following ICH-GCP and ISO14155 standards.

He coordinates the daily activities of clinical studies, setting priorities for each site and ensuring data integrity and patient safety. Ziane plays a key role in managing queries and reports while maintaining the TMF and project tracking systems.

He works closely with Clinical Managers to address trial issues, participates in investigators’ meetings, and undergoes ongoing training to enhance his therapeutic knowledge. As a mentor to other CRAs, he shares best practices and expertise.

Additionally, he may take on country-specific or project-specific responsibilities, such as site management, regulatory oversight, or contract management, as needed. His proactive approach ensures timely and quality delivery of clinical data and project outcomes.

• Prepares and delivers quality monitoring reports per timelines.

• Ensures data integrity and patient safety during site monitoring (onsite/remote).

• Conducts site visits (qualification, initiation, monitoring, close-out) as per monitoring plan.

• Maintains and updates Trial Master File (TMF/eTMF) per ICH GCP guidelines.

• Resolves queries with sites and supports Data Management processes.

• Collaborates with Clinical Manager/Lead to manage site visits and address trial issues.

• Ensures compliance with protocols, regulations, and quality standards.

• Tracks site and subject information, assisting with recruitment and feasibility.

• Participates in Investigator Meetings and project team activities.

• Reviews investigational product accountability and essential logs.

• Provides mentorship to junior CRAs and shares best practices.