Daniel Maldonado

Bis 2018, Director Country Operations, Chiltern International Ltd

Mexico City, Mexiko

Fähigkeiten und Kenntnisse

Biochemistry and Molecular Biology
Good Clinical Practice
Regulatory Affairs
Pharmacovigilance
Clinical Project Management
Clinical Development Strategy
Start-up
Healthcare Compliance
Biotechnology
Feasibility Studies
Teambuilding
Clinical Operations
Bioequivalence Studies
Vaccines
Phase I to IV
Health Economics and Outcome Research
Monitoring
Clinical Trials
Supervision

Werdegang

Berufserfahrung von Daniel Maldonado

  • Bis heute 6 Jahre, seit Juni 2018

    Founder

    Revol CRC

  • 2 Jahre und 5 Monate, Jan. 2016 - Mai 2018

    Director Country Operations

    Chiltern International Ltd

  • 1 Jahr, Feb. 2015 - Jan. 2016

    Assoc Manager Clinical Monitoring

    Chiltern International Ltd

  • 2 Jahre und 1 Monat, Feb. 2013 - Feb. 2015

    Director, Clinical Development

    Innovare R&D

    Clinical R&D in accordance to local and international regulatory landscape and business strategic needs Clinical Operations Project Management Pharmacoeconomic and Health Outcome Research studies Pharmacovigilance implementation BA/BE clinical strategy Healthcare Compliance implementation Therapeutic areas: Infectology (HIV), Hematology, Immunology and Intensive Care

  • 1 Jahr, Jan. 2012 - Dez. 2012

    Regional Clinical Trial Manager LATAM

    Synthon

    Strategic Project Management for BA/BE studies and international clinical trial in Mexico, Brazil and Chile. Therapeutic áreas: Multiple Sclerosis (Phase III: Bio-similar Product & Generic BE), Oncology (Phase III: Bio-similar & Generic BE), CNS (Generic BE), Cardiovascular (Generic BE), Urology (Generic BE).

  • 3 Jahre, Jan. 2009 - Dez. 2011

    Sr. Clinical Research Associate

    ReSearch Pharmaceutical Services, Inc.

    Site and Country feasibilities, Site Qualifications, Site Initiations, Site Monitoring Visits, Site Close-out Visits and Co-Monitoring Visits, performed on Phase I to III International Clinical Trials for the next therapeutic areas: Pediatric Vaccines, Pediatric Hematology (biotechnology product), Transplants- Nephrology, Rheumatology (biotechnology product), Orthopedics (biotechnology product), Pediatric T2DM, Hematology (biotechnology product) and Ophthalmology.

  • 1 Jahr und 7 Monate, Juli 2007 - Jan. 2009

    Clinical Research Site Manager

    Global Clinical Operations Johnson & Johnson

    Start up participation for an international phase III infectology (HIV) trial. Implementation, supervision and monitoring for international phase III psychiatry trial including SIV, SMV and SCOV. Implementation, supervision and monitoring for international phase IIb Metabolic trial, including SQV, Start-up, SIV, SMV and SCOV. Country and site feasibilities for an international phase III neuropathy trial.

  • 2006 - 2006

    Clinical Research Associate

    Pfizer

Ausbildung von Daniel Maldonado

  • 2015 - 2015

    Biopharma Innovation

    Rutgers University

  • 2014 - 2014

    Health Care Compliance

    IPADE

  • 2013 - 2013

    Pharmacoeconomics

    Universidad Nacional Autónoma de México

  • 2012 - 2012

    Bioequivalence

    Universidad Nacional Autónoma de México

  • 2010 - 2010

    Clinical Research Project Management

    IEEC - International Executive Education Center

  • 2009 - 2020

    Biotechnology Project Management

    University of California, San Diego

    Biotech Project Management Professional Certificate

  • 2004 - 2006

    Biochemistry

    Universidad Nacional Autónoma de Mexico

    Protein-protein interaction, Cell Signaling, Molecular Oncology

  • 2001 - 2003

    Molecular Biology

    Georg August University of Göttingen

    Biochemistry, Cell & Molecular Biology

  • 1996 - 2000

    Biology

    Universidad Nacional Autónoma de México

    Genomic Medicine and Environmental Toxicology

Sprachen

  • Englisch

    Fließend

  • Spanisch

    Muttersprache

  • Deutsch

    Grundlagen

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