Paula Valle

Clinical research projects - Initiation of international trials: site feasibility, site selection, budget management and contract negotiation. - International trial management: oversight of project timelines, deliverables and milestones in a timely and quality-compliant manner. Oversight at planning, execution and follow-up stages. - Ethical/regulatory submissions and implementation of protocol amendments. - EDC design, set up, training and oversight. - Generation of project quality metrics and implementation of corrective actions - Stakeholder liaison and cross-functional collaboration: transparent and trustworthy communications with international investigators, internal team, vendors and regulators - Medical writing: protocol, abstract, manuscripts, scientific papers, grant applications, ICF, CSR Health technology projects - Develop hospital-level infrastructure aligned with European Health Data Space (EHDS) objectives - Support the creation of a federated learning system for paediatric transplant patients in Europe, including data model development and assessment of data access, migration, and privacy challenges - Serve as a bridge between clinical and technical teams, ensuring alignment of functional and domain-specific requirements.

PhD in the field of Precision Medicine in Paediatric Oncology. Title: Implementation of a Molecular Tumor Board in the Paediatric Oncology Department of La Paz Hospital in order to optimise therapeutic decision-making in patients with oncogenic alterations but no readily available drugs. My duties as a scientific advisor in the MTB included: - Planning and execution of medical advisory boards - Scientific content development, discussion and dissemination - Assesment of drug safety and efficacy data to support evidence based therapeutic decision-making - Address of scientific queries from clinical team on experimental drugs. - Experienced scientific data reviewer, presenter and educator - Real World Evidence registry creation - Cross-functional liasion with key investigators and sponsors. Multidisciplinary team coordination - Medical data communicator, MoA expert, Oncology expert, evidence-based medicine expert, Oncology clinical development lifecycle expert

Oncology clinical trial execution at clinical site, responsible for the management of up to 30 clinical trials. Some of my main duties include: - Clinical Trial protocol adherence (visit planning, proper efficacy and safety assessment) - Protocol Deviation tracking - Patient identification, recruitment and retention - Cross-functional collaboration and liasion (with sponsor/CRO, data managers, regulators) - Peer-to-peer education and scientific training at site level (clinicians, nurses, lab tecnicians) - Multidisciplinary team coordination - Data management: AE/SAE identification and reporting, query resolution, source data verification support, Trial Master File Support

This master degree has given me a profound knowledge of some essential aspects of clinical research such as research methodology, biostatistics and scientific writing. This education has empowered my activity as a clinical research coordinator and, in general lines, my skills as a scientist working in a highly competitive and constantly evolving environment. Master´s Final Thesis: Therapeutic optimization of childhood cancer therapeutics based on personalized medicine. Construction of a database of targeted drugs for paediatric oncology,

Major on Biology of cancer.