Leveraging over 17 years of experience in clinical operations and translational medicine, I specialize in sample and data management to support clinical projects, including those focused on biomarkers, companion diagnostics (CDx), and rare diseases.📝 Protocol and consent design and review, support to ethic committees questions🔗 Vendor management (central labs, biobanks, global CROs)✔️ Vendor qualification audits and follow-up🧪 Clinical biobank development and management including governance 🎯 Sample acquisition strategy🤝 Partnership and consortium management🔄 Interim management🔍 Due diligence📚 Training on regulations and risk management in human biosample

Accountable for ensuring regulatory guidance, securing access, and facilitating the use of biological samples from Central Biorepository and external sources for R&D and partnerships projects.Manage the Central Biorepository:- Make sure patient consent & rights are respected.- Maintain knowledge and consistency of the inventory.- Guarantee reliability of biosample (quality requirements) and biosample data (integrity, tracking, completeness).- Facilitate data sharing with other Biosample/Clinical databases. Manage Central Biorepository team (internal & insourcing).Ensure Central Biorepository governance and biosamples valorisation:- Lead the implementation of visualisation tools, based on internal data repositories and sample data categorization , dedicated to decision making and to facilitate biosamples access to R&D teams. - Define with the R&D teams the sample collection strategy for R&D projects and ensure its proper implementation with the operational teams.Responsible of SOPs/OPMs and training of actors involved in the management of Central Biorepository biosamples.Pilot the policy and promote good practices for managing human biosamples (clinical studies, partnerships).Act as an expert, point of contact with the competent authorities and partners for topics related to biosample management and biosample valorisation: - Ensure ethic & regulatory guidance as regards human biosamples within R&D including potential transfers to partners, new partnerships.- Control the risks (GCP, regulatory, GDPR, ethics, security, etc.) related to the management, purchase from external Biobanks, reuse of biosamples within R&D.- Participate in data integrity and system audits.

Responsible for company’s Central Biorepository (long-term storage of human biological samples for retrospective analysis). Process referent for Biorepository and human biological sample management for R&D Projects.- Directed the setup and optimization of Biorepository tools and processes, functional subcontracting implementation, and technology watch monitoring.- Developed and implemented major SOPs/OPMs and policy dedicated to biological samples (human biological sample management, biomarkers, clinical protocol, patient consent).- Promoted sample management initiatives (centralization, homogenization, education, cost optimization)- Managed ethical and regulatory acceptability questions related to biological samples in accordance with clinical protocols, patient consent, international and local regulations.- Planned, supervised and coordinated activities with the clinical and research teams and subcontractors (resource and budget management).

Responsible for managing Centralized Biology activities on phase II/III studies (multicentric and international) - Managed Central Labs and Logistic Platform activities (Kits: conception and supplying; biological samplings: samples processing, logistics and analysis).- Planned, supervised and coordinated activities with study team (Request for Proposal, subcontractor selection, documentation, resource and budget management).- Co-developed the setup of Central Biology processes.

Specialized in Phase I healthy volunteers clinical trials (Pharmacokinetic, First in Man, Food effect, MTD, Bioequivalence trials)- Managed over 40 paper and eCRF trials.- Planned, supervised and coordinated activities with subcontractors (15 CROs).- In charge of clinical protocol review, creation/review of annotated CRF, Clintrial database and edit checks setup, data review, database lock.- Directed and implemented migration (pilot study, process and tools) from paper CRF to eCRF.