Experience

Amadix

• Spain
• Biotechnology Research
• 1 - 100 Employee

• Clinical Affairs Manager

  • Feb 2022 - Present

  Management of the Clinical Affairs and Clinical Operations team:- Oversight of team members' work, prioritizing and giving support on assigned tasks- Definition of objectives and performance review Clinical Project Manager:- Management of national and international clinical projects of the company for the clinical development of an IVD test for colorectal cancer early detection in blood

• Clinical Affairs

  • Jul 2018 - Jan 2022

  Clinical study leader: oversight of assigned clinical projects, coordination of team members to ensure compliance with timelines and objectives.Management of an international multicentric study for the clinical validation of a blood diagnostic test for colorectal cancer, conducted in Germany and Poland.Responsible for the presentation of an IVD product to the American FDA (attendance to and preparation of the Pre-submission meeting).Selection and management of international vendors.Maintenance of in-depth knowledge of the literature related to the assigned product and pathology.Writing of deliverables for the justification of a H2020 grant. Participation in the generation of the Technical File of an in vitro diagnostics for CE marking obtention. Show less



Venter Pharma SL

• Spain
• Biotechnology Research
• 1 - 100 Employee

• Medical Affairs Officer

  • Mar 2015 - Jul 2018

  -Responsible for the management of a phase IV multicentric clinical trial with a diagnostic drug for hypolactasia: Periodic meetings with the investigators (scientific support) Preparation of the documents (protocol, informed consent) Coordination of work with CRO and supervision of the monitorization Follow up of the trial conduct: recruitment, medication shipment, deviation management Result analysis and generation of the Clinical Study Report Communication of results in meetings and publications - Writing of scientific articles for their publication in international journals -Writing and/or review of reports for the Spanish Agency for Medicines and Medical Devices (DSUR, expert reports, investigator brochure...) -Participation in the analytical validation of an in vitro xylose measurement technique for diagnostic use - Generation of presentations addressed to physicians or review of presentations of the Business Development Department Show less



Universidad Complutense de Madrid

• Spain
• Higher Education
• 700 & Above Employee

• Predoctoral researcher

  • Mar 2008 - Mar 2013

  Doctoral thesis: "Immunomodulatory properties of a synthetic pulmonary surfactant based on human recombinant protein SP-C: mechanism of action and role of its components." Knowledge about lung anatomy and immune system Writing of scientific articles Presentation of results in national and international meetings Doctoral thesis: "Immunomodulatory properties of a synthetic pulmonary surfactant based on human recombinant protein SP-C: mechanism of action and role of its components." Knowledge about lung anatomy and immune system Writing of scientific articles Presentation of results in national and international meetings