About Beatriz
With 13+ years in EU oncology clinical research - across CRO, FSP, and sponsor-embedded roles - I help pharma companies, biotechs, and CROs keep their trials on track, inspection-ready, and patient-focused.
My experience spans Phase I FIH through Phase III across multiple solid tumour indications, in six EU markets. With additional experience in ophthalmology and neurology.
I work with:
Small biotechs needing senior clinical ops without full CRO cost
CROs needing experienced EU freelance coverage for oncology sites
Mid-size pharma sponsors needing field expertise with strategic delivery
What I bring:
✓ Site and patient engagement protecting recruitment timelines
✓ TMF/ISF management and inspection readiness (Veeva Vault)
✓ Feasibility intelligence and RFI/RFP input for site selection
✓ Protocol deviation management and data integrity oversight
✓ Cross-functional coordination: sites, DM, Safety, vendors
Available remotely and on-site across the EU.
ES
Con más de 13 años en investigación clínica oncológica en Europa - en roles CRO, FSP y sponsor-embedded - ayudo a compañías farmacéuticas, biotechs y CROs a mantener sus ensayos en plazo, listos para inspección y centrados en el paciente.
Mi experiencia abarca Fase I FIH hasta Fase III en múltiples indicaciones de tumores sólidos, en seis mercados europeos. Con experiencia adicional en oftalmología y neurología.
Trabajo con:
Biotechs pequeñas que necesitan soporte senior sin el coste de una CRO
CROs en busca de cobertura freelance experta en oncología EU
Sponsors farmacéuticos medianos que necesitan expertise de campo y visión estratégica
Lo que aporto:
✓ Engagement de centros y pacientes que protege el reclutamiento
✓ Gestión de TMF/ISF e inspection readiness en Veeva Vault
✓ Inteligencia de viabilidad y aportación a RFI/RFP
✓ Gestión de desviaciones de protocolo e integridad de datos
✓ Coordinación interfuncional: centros, DM, Safety y proveedores
Disponible en remoto y presencial en toda la UE.
Spanish
Native or bilingual
English
Fluent
French
Basic
Catalan
Native or bilingual
Remote only
Primarily works remotely
Experience
- ICON / Astellas FSP – Oncology EDTSClinical Site Manager IIPHARMACEUTICALS INDUSTRYApril 2025 - December 2025 (8 months)Barcelona, SpainSponsor-embedded site management role across early-phase oncology studies (Phase I FIH; lung cancer incl. NSCLC and colorectal cancer).• Central coordination point between clinical sites and global study teams (Project Leaders, Medical Monitors, Data Management, Safety, Regulatory, vendors), ensuring alignment with protocol requirements and timely delivery.• Conducted on-site and remote monitoring visits; reviewed source documents and CRF data for accuracy and completeness; identified and followed up on protocol deviations and pharmacovigilance issues.• Maintained TMF and ISF in Veeva Vault ensuring completeness, version control and inspection readiness; tracked and reconciled IP inventory and ancillary supplies at site level.• Maintained continuous site engagement, translating site constraints and patient pathway realities into mitigation plans to protect visit continuity and key milestones.• Monitored trial progress using CTMS dashboards and risk indicators; surfaced issues early with mitigation proposals to sponsor governance.
- Syneos Health – Oncology EUSite Relationship LeadPHARMACEUTICALS INDUSTRYApril 2022 - December 2023 (1 year and 8 months)Barcelona, SpainStrategic site-facing role managing a portfolio of EU oncology sites across the full study lifecycle, with responsibility for site performance, patient engagement and pre-award activities.• Owned a portfolio of high-performing EU oncology sites, maintaining deep intelligence on site capabilities, patient pathways, therapeutic focus and institutional priorities.• Delivered strategic site intelligence for RFI/RFP/award activities, translating investigator interest, feasibility findings and patient recruitment potential into actionable recommendations on site selection and country mix.• Contributed to protocol and operational design optimisation (I/E criteria, visit burden, patient pathways) to strengthen feasibility, recruitment and retention strategies.• Participated in advocacy groups and KOL forums, facilitating early scientific and operational input during proposal and award-stage discussions.• Managed strategic site partnerships under framework agreements, leading structured due diligence and periodic site assessments to de-risk delivery.• Coordinated cross-functional delivery with Clinical Operations, Feasibility and Therapeutic Area Leadership to ensure sites were prepared and activated on time.
- Syneos Health – FSP MSD Oncology | Neurology BUSenior Clinical Research AssociatePHARMACEUTICALS INDUSTRYMarch 2020 - March 2022 (2 years)Barcelona, SpainSenior FSP monitoring role across oncology (MSD), ophthalmology and neurology trials; EU-level CRA coordination within the Neurology Business Unit.• Senior-level on-site and remote monitoring across oncology, ophthalmology and neurology programmes; SDV/SDR, query resolution and data integrity management per ICH-GCP and sponsor SOPs.• Reviewed and quality-checked CRA pre-study visit reports prior to sponsor submission; provided EU-level guidance to CRAs on monitoring standards and reporting requirements.• Supported data review through regular query follow-up with sites and collaboration with Data Management; reviewed ISF for completeness and reconciled with TMF.• Close collaboration with investigators, site staff and sponsor representatives to maintain protocol adherence, study momentum and issue resolution.
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Education
- Master's DegreeCESIF Business School2018Master's Degree in Clinical Trials Management
- Master's DegreeESAME Business School2012Master's Degree in Clinical Trials Monitoring