Valeria Del Castillo
Buenos Aires
Summary
Dynamic professional with extensive experience in clinical research trials, recognized for exceptional organizational skills and a collaborative spirit. Proven track record of delivering outstanding results aligned with MSD's Enterprise Leadership Skills, consistently achieving a 180° leadership assessment above benchmark across all categories. Expertise in developing multiple therapeutic areas without prior local experience by leveraging strategic communication to identify key opinion leaders and drive top 10 country performance. Known for clear and objective communication, simplifying complex concepts, setting ambitious goals, and fostering a trusting environment that encourages idea sharing and support.
Overview
23
23
years of professional experience
Work History
TAH
MSD
09.2020 - Current
- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
- Proven ability to learn quickly and adapt to new situations.
Clinical Project Manager
Schering-Plough Pharmaceutical
03.2009 - Current
- In charge of 4 clinical trials of 3 therapeutic areas: Immunology – Infectology – Oncology. Two of them with Biologic drugs.
- Participation in preparing sites for HA Inspections and during Inspections.
Sr. Clinical Research Associate
Schering-Plough Pharmaceutical
06.2007 - 03.2009
- Rol of lead Sr. CRA for Cardiovascular mega trial, for selection, start up process and monitoring of sites. Site management for 9 sites including the top-enroller with 118 subjects.
- Accomplishment commitment of randomized subjects of the selected sites. PM’s back-up for this trial with 35 sites.
- Participation in Sponsor´s Audit of top enroller site: 4 minor findings.
Medical Coding Specialist – Data Management
Schering-Plough Pharmaceutical
06.2006 - 06.2007
- Encoding under ICH of all Adverse Events (Death/LT, Serious, Non-Serious and Other) of different therapeutic areas with regard to research trials and the once corresponding to Global Pharmacovigilance.
- Dictionaries maintenance (MedDRA, WhoDrug and Company ones)
Medical Safety Officer – Clinical Research and Development
Wyeth Pharmaceutical
01.2005 - 03.2006
- Ensuring compliance with the regulatory standards in the Serious Adverse Event reporting process and all safety expedite reports.
- Responsible for receiving, reviewing and submitting Serious Adverse Events from the site to the Global Medical Monitor for all ongoing studies; including completion of forms for the assessment on causality of test article.
- Acting as a liaison with sites and the Clinical Team in relation to Serious Adverse Event reporting
- Providing appropriate follow-up with the site and the Clinical Team on safety questions/concerns
- Responsible for performing Case narratives for particular patients
- Monitoring cases of Emergency Use (IND drug).
- Review and approval of additional tests (non-protocol procedures) for enrolled subjects
- Giving presentations at Investigator Meetings.
Clinical Research Associate – Argentina & Peru
Wyeth Pharmaceutical
04.2003 - 06.2005
- Experience in two different type of studies:
- Acute Infectious disease Area [short term studies; multiple sites] Argentina and Perú.
- Site selection, initiation visit, train and monitoring sites
- Prepare pre-study documentation. Review and correct protocol translations, prepare country-specific Informed Consent Forms. Submit protocols to IEC/IRB and MOH.
- Work with Medical Monitor in the communication of scientific data to sites.
- Provide the medical team Case Narratives for particular patients.
- Perform close-out visits.
- Chronic Metabolism disease, [long term study].
- Monitoring over 125 patients
- Drug accountability
- Provide medical team Case Narratives for particular patients
Education
ACRP Certified -
ACRP
01-2025
PMP Certified -
Project Management Institute
12-2016
MS - Clinical Pharmacological Research
Universidad Abierta Interamericana
Argentina01-2006
M.D. -
School of Medicine, Universidad Austral
Buenos Aires, Argentina12-2001
Skills
- Friendly, positive attitude
- Teamwork and collaboration
- Customer service
- Problem-solving
Cursos de Pós-Graduação
- Mestrado em Pesquisa Farmacológica Clínica, Universidad Abierta Interamericana, Buenos Aires, Argentina (2003-2006)
- Workshop em Comitês de Ética, Foro Latinoamericano de Comitês de Ética em Investigação em Saúde (FLACEIS) (2003)
- Curso de Farmacoepidemiologia, Academia Nacional de Medicina, Buenos Aires, Argentina (Ago-Oct2003)
- Curso de Monitorização de Ensaios Clínicos & Boas Práticas Clínicas (ICH/GCP), Associação Médica Argentina (2002)
Timeline
TAH
MSD
09.2020 - Current
Clinical Project Manager
Schering-Plough Pharmaceutical
03.2009 - Current
Sr. Clinical Research Associate
Schering-Plough Pharmaceutical
06.2007 - 03.2009
Medical Coding Specialist – Data Management
Schering-Plough Pharmaceutical
06.2006 - 06.2007
Medical Safety Officer – Clinical Research and Development
Wyeth Pharmaceutical
01.2005 - 03.2006
Clinical Research Associate – Argentina & Peru
Wyeth Pharmaceutical
04.2003 - 06.2005
ACRP Certified -
ACRP
PMP Certified -
Project Management Institute
MS - Clinical Pharmacological Research
Universidad Abierta Interamericana
M.D. -
School of Medicine, Universidad Austral