Isabel Salcedo De Diego
Madrid
Summary
Strong team builder and problem-solver healthcare professional dedicated to develop clinical procedures and infrastructure required to support the delivery of drugs, cell and gene therapies from the clinical site.
International sound clinical and research background in UK, Australia and Spain, willing to extend the know how achieved in clinical research and quality management positions over the last 17 years to the pharmaceutical innovative sector, with the ultimate aim of increasing the access of patients suffering from cancer to research and marketed drugs and advanced therapy medicinal products.
Overview
22
22
years of professional experience
Work History
Advanced Therapies Coordinator and Quality Manager
Hematology Department, Hospital Universitario Puerta de Hierro Majdahonda
2021.01 - Current
- Key role in delivery of Advanced Therapy Medicinal Products (ATMP) by providing leadership and education for delivery of ATMP in conjunction with multi-disciplinary teams.
- Research coordinator for cellular and ATMP clinical trials.
- Quality manager for JACIE accreditation, Europe’s only official accreditation body of haematopoietic stem cell transplantation (HSCT) and cellular therapy.
- Responsible for Onboarding site qualifications for marketed and research CAR-T therapies following manufacturers´quality requirements.
- Delivery of patient efficient CAR-T journey.
- Coordination, oversight and support of periodic internal and external audits to evaluate product and processes quality and safety and address non-conformities.
- Development and updating of quality control standards, methods, and procedures to meet compliance requirements.
- Design and implementation of continuing education programs for healthcare professionals.
Lead Clinical Trial Coordinator
Fundación de Investigación Biomédica del H.U. Puerta de Hierro Majadahonda
2006.10 - 2020.12
- Start up of a Multidisciplinary Clinical Trial Unit in the Clinical Pharmacology Department.
- Coordination of over 200 phase I-IV clinical trials, covering more than ten medical and surgical specialties including Oncology, Hematology, Stem Cell Transplantation and Infectious diseases, among others.
- Accreditation of Phase I Unit; Site preparation for quality assurance sponsor audits and inspections (AEMPS, FDA).
- Main site level contact for sponsors, CRO and Research Committees.
- Direct patient care, data management, reporting of adverse drug reactions, pharmacovigilance activities, budget management, research team oversight in accordance with Good Clinical Practice.
- Start up and Monitoring activities as member of the Spanish Clinical Research Network (SCREN), Spanish partner of ECRIN since 2015.
- Member of the Research Committee for seven years.
Associate Professor
Universidad Autónoma de Madrid and Universidad Europea, Nursing Departments
2017.09 - Current
- Contribute directly to Undergraduate and Master programs through research-led teaching, student mentoring and supervision of student research projects.
- Areas of lecturing expertise: Quantitative Research Methodology, Evidence-Based Practice, Ethics in Research and Patient Care, Public Health and Epidemiology, Vulnerable Populations.
Staff Nurse
Royal Prince Alfred
2003.12 - 2006.08
- Nursing care in Surgical Theatres and Recovery Unit as a scrub, circulating and recovery nurse in a multidisciplinary and international environment.
Staff Nurse
Derriford Hospital NHS Trust
2002.01 - 2003.08
- Monitoring of surgical patients and delivery of quality level of nursing care before, during and after operations to promote positive outcomes.
Education
Ph.D. - Medicine and Surgery
Universidad Autónoma de Madrid
06.2017
Master of Public Health And Epidemiology (MPH) -
Universidad Rey Juan Carlos
06.2009
Bachelor's Degree - Nursing
Universidad Autónoma De Madrid
06.2001
Bachelor's Degree in Speech And Language Therapy -
Universidad Complutense De Madrid
06.1998
Skills
- Team leader and builder
- Decision making, difficult issue resolution capacity
- Ethical and fair approach to team and projects oversight
- Ability to prioritize and work under pressure to meet expectations within timelines.
- Excellent communication and organizational skills
- Data Management in highly used CRF softwares.
- Statistical Analysis, SPSS, Stata
- External audit support and internal audit performance
- Quality accreditation processes, SOP and CAPA Development
- Implementation and Delivery of Education Programs
Accomplishments
- Scientific Publications in high impact factor journals: https://orcid.org/0009-0007-1976-320X
- Over 30 Oral and Poster communications at international scientific meetings.
- Member of the Research Ethics Committee at Hospital Universitario Puerta de Hierro Majadahonda HUPHM (2008-2015).
- Member of the EBMT Nurses Research Committee since 2019. Local organiser of the EBMT 2020 and 2021 annual meeting with over 6.000 attendees.
- Chair of GETH (Spanish Stem Cell Transplant and Cellular Therapy Scientific Society) Nurses Research Group.
- Member of the Risk Management Unit at HUPHM (2014-2018).
- Editor assistant at Metas de Enfermería (Spanish Nursing Journal) since 2011.
- Willing to travel according to job requirements up to 50% of the time.
- Passionate about travelling with special interest in diving (Advanced PADI certified) and local gastronomy. Over 50 countries visited in all five continents.
Timeline
Advanced Therapies Coordinator and Quality Manager
Hematology Department, Hospital Universitario Puerta de Hierro Majdahonda
2021.01 - Current
Associate Professor
Universidad Autónoma de Madrid and Universidad Europea, Nursing Departments
2017.09 - Current
Lead Clinical Trial Coordinator
Fundación de Investigación Biomédica del H.U. Puerta de Hierro Majadahonda
2006.10 - 2020.12
Staff Nurse
Royal Prince Alfred
2003.12 - 2006.08
Staff Nurse
Derriford Hospital NHS Trust
2002.01 - 2003.08
Ph.D. - Medicine and Surgery
Universidad Autónoma de Madrid
Master of Public Health And Epidemiology (MPH) -
Universidad Rey Juan Carlos
Bachelor's Degree - Nursing
Universidad Autónoma De Madrid
Bachelor's Degree in Speech And Language Therapy -
Universidad Complutense De Madrid
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