Lausanne, Vaud, Switzerland
MS in Biochemistry, I worked as a quality consultant, and quality and environment responsable in a company, thanks to the Master in quality and environment I coursed. After that, I wanted to change my professional way, and I coursed a Master in Drug R&D. I started as a CRA Trainee in AbbVie, to follow as CRA in Quintiles. Another job has been as a Clinical Scientist in Medical Affairs in the Ferring global team, and my last position has been as a Clinical trial Coordinator at Spineart, in the field of medical devices related to spine surgeries. Currently, I am in an active search for a new opportunity in Switzerland or Spain Specialties: Clinical research, Quality management, GCP/ICH,System & Process improvement, non-compliance and indicators analysis.
Responsibilities: Supporting the conduct of Spineart clinical studies from set-up to closure. Developed task: Responsible for the Trial Master File and ensuring it is complete and audit ready. Study protocol and other essential document formatting and QC checks, submission package preparation, and QC checks as needed. Responsible for study closure and archiving as assigned. Tracking clinical study spending versus budget, verifying and managing invoices. Manage site and vendor contract process, filing, and tracking. Responsible for meeting organization as needed (e.g. investigator meetings). Organization and filing of scientific publications. Supports the clinical project manager in all site-related study activities including submissions, site document preparation, site support during the study, and supporting the study monitoring process.
Responsibilities: Project management activities within the medical affairs team, in the frame of a new gene therapy product for the treatment of patients suffering from Non-Muscle Invasive Bladder Cancer. Developed tasks: Participation in the development of the medical plan and scientific platform Preparation of contracts, keeping investigator´s profiles updated, requesting invoices and preparing purchase orders, budget oversight Management of external stakeholders and coordination of their participation in various projects/activities (advisory board meetings, congresses, stand-alone meetings, etc.) Project & Team development documents’ review (Disease awareness campaign materials, scientific training decks, Q&A documents...) Organization of new scientific management tools (e.g. timelines & budgets control) Reference searching
Developed tasks: • Clinical study sites management • Preparation and performance of monitoring visits, and close out visits, both onsite and remote; follow up and write visit reports. • Pharmacy visits. Accountability of Investigational product, management of provided product and returned product. • Management of eCRF (Medidata RAVE and Oracle Inform). Revision of queries, PI signatures, reports… • Update and maintenance of Trial Master File. • Contact with different study vendors (Bracket, Histogenex…) as part of site management
Developed tasks: o Revision of: protocols, amendments and Informed Consents prior to submission to Ethics Committees and Spanish Agency, including translation verification and validation to Spanish. o Revision of eCRF drafts. o Preparation and performance of accompanied initiation visits, re-training visits, monitoring visits, and close out visits; follow up and collaboration in writing the visit reports. o Revision of studies master files. o Providing assistance during studies start up, including preparation of documents for submission to Ethic Committees and Spanish Agency. o Preparation of internal reports and department meetings presentations. o Collaboration in launching a web page for recruited patients. o Revision of SOPs for update. o Attendance to Investigator meeting.
Main tasks: o Quality and environment system maintenance (based in ISO 9001:2008, and ISO 14001:2004 standards.) -Follow up and analysis of objectives and indicators. -Follow up and analysis of Non Compliance o Implantation and maintenance of OHSAS 18001:2007 Standard. o Preparation of environmental reports and waste management studies o Preparation of safety plans. o Carrying out Internal Audits and preparation and attendance to External Audits Other tasks: o Administrative relationships with Town Hall, and Local Government (Comunidad Autonoma de Madrid). o Relationship with suppliers. o Economic management. o Control of Staff documentation. o Control of applicable legislation