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.

THERAPEUTIC AREA & PHASE Interventional studies: - Oncology Phase I/II (Metastatic Castration-Resistant Prostate Cancer) - Oncology Phase I (Advanced Epithelial Ovarian Cancer) - Oncology Phase III (Soft Tissue Sarcomas) - Neurology Phase III (Charcot-Marie-Tooth Disease Type 1A - Neonatology Phase III (Prevention of Necrotizing Enterocolitis in Premature Infants) - Rare Disease Phase II/III (Primary Hyperoxaluria) - Onco-Dermatology Phase III (Basal Carcinoma Cells) Skills: • 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.

THERAPEUTIC AREA & PHASE Interventional studies: - Gene therapy Phase I/II/III study with a dose determination (Duchenne Muscular Dystrophy) - Respiratory disease Phase Ib/IIa (Sever Community- Acquired Bacterial Pneumonia) - Onco-Dermatology Phase III ( Basal Carcinoma Cells) - Respiratory disease Phase Ib/IIa (Sever Community- Acquired Bacterial Pneumonia) - Ophthalmology Phase III (Macular degeneration) Observational studies: - Neurology (Schizophrenia) - Oncology (Metastatic Colon Cancer) - Nephrology (Acute Renal Failure) - Blood disease (Leukaemia) - Rare disease (Duchenne Muscular Dystrophy) Medical Device: - Cardiovascular disease SKILLS: - Site Initiation visits - Site visit reports, confirmation and follow-up letters - Close out visit - Regulatory documents collection - Site follow-up - Site staff training - TMF updating activities (electronic and paper) - Writing the monitoring/guide monitoring plan - Dissemination of substantial / non-substantial changes - initiation visit (remote and on-site) and monitoring - Regularization of the NIFC and report of deviations to the protocol - Follow-up of the pharmacy dispensation - Follow-up of laboratory samples - EC Submission

Caractérisation en hémostase d’un model de souris déficientes en SERCA3