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Experiences

Current Experience

  • Junior Consultant London, United Kingdom
    Since February 2016

    Working on a business analysis project with Teva UK Ltd, modelling both the Sales and Marketing efforts and Local Health Economy policy that produces differential commitment, implementation, and adoption of a pharmaceutical product on individual prescribers and/or the Primary Care Organisations.

Past Experience

  • Senior Clinical Research Associate (CRA) Lima, Peru
    February 2012 --- September 2015

    Monitor in house assigned to Merck Sharp & Dohme projects

    Manage clinical trial progress, ensuring that it is recorded, conducted and reported accordance with SOPs, protocol, Good Clinical Practice (GCP), and the relevant regulatory requirements. Provided training and protocol management in the assigned site.

    Projects associated to the following therapeutic areas:

    • Rheumatology: Rheumatoid arthritis, Osteoporosis, (Study phase II - III)
    • Oncology / Paediatric Oncology (Study phase IIb – IV)
    • Infectious diseases / Vaccines: (Study phase II – III)
    • Endocrinology (Study phase III).

  • Clinical Research Associate (CRA) Madrid, Spain
    January 2011 --- January 2012

    Manage clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines. Reviews and verifies accuracy of clinical trial data collected, either on site or remotely. Performs source document verification and query resolution. Assesses IP accountability, dispensation, and compliance at the investigative sites. Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.

    Projects associated to the following therapeutic areas:  

    • Neurosciences: Insomnia, Migraine (Study phase III)
    • Rheumatology: Rheumatoid arthritis, Osteoporosis, (Phase II - III)
    • Oncology / Paediatric Oncology (Study phase IIb – IV)

  • Regulatory Affairs Associate Lima, Peru
    October 2008 --- October 2009

    • Prepare dossier for registration of pharmaceuticals products: First registration, Renewals; other changes (formula changes, labelling changes) and until tracking of each dossier submitted to the Regulatory Agency.
    • Investigate regulatory history of similar products to assess approval implications before to submit to the MoH.
    • Conduct research on submission requirements and alternatives, also responding to regulatory information requests.
    • Compile and organize materials for pre-submission reports, coordinate and assist in the preparation of submission/registration packages and coordinate registration requests and track completion.

  • Medical Department Internship Lima, Peru
    January 2007 --- September 2008

    I had the oportunity to work in two areas:

    As part of the Job Responsibilities as Clinical Research Trainne: 

    • Supervising and controlling the local packing and/or labelling process of the clinical supplies or study medication according to local regulation, when was applicable.
    • Perform the inspection and subsequent release of study medication according to compliance with the specifications and the authorization issued by the Health Agency.
    • Monitoring the storage conditions of study medication or clinical supplies.
    • Review the list of drugs to destroy physically, verifying the destruction process and assist in the coordination of the destruction of study medication.

    As part of the Job Responsibilities as Regulatory Affairs Trainne:

    • Prepare records for obtaining sanitary registration and renovation of records.
    • Perform the inspection of pharmaceutical products (coming from imports) following quality specifications.
    • Tracking the status of filings submitted to the Health Agency.
    • Make electronic and physical file, as well as the management of regulatory documents of each pharmaceutical product.

Personality

Self Assessment :
Problem solvingAssertivenessApproachabilityAuthenticityCommunicativeCuriosityOptimismOrganizationResiliencySelf-confidenceSelf-disciplineSociability

Knowledge

Self Assessment :
CoachingClinical researchCurrent Good Manufacturing Practice (CGMP)ICH guidelinesmolecular biologyMolecular genetics BiochemistryGCP R&DBusiness DevelopmentClinical trialsClinical Trial Management System (CTMS)CRFDrug AccountabilityDrug Safety and PharmacovigilanceEnglishGood Clinical Practice (GCP)Team ManagementTeamworkSupply Chain ManagementSerious Adverse Event (SAE)Regulatory affairsQuality ManagementQuality Assurance (QA)Project ManagementProblem SolvingProblem-solving methods and troubleshootingPowerPoint
LinkedIn Assessment :
Regulatory submissionsRegulatory affairsClinical trialsClinical researchGCPPharmacovigilanceICH-GCPCoachingClinical DevelopmentPharmaceutical Industry

Skills and Expertise

Self Assessment :
Interact with physicians Interact with nurses Monitor a clinical study Report data Search literature on clinical trialsAdjust processes Adverse event reportingApprove queriesApprove suitability of patient information and consent documentsArchive documentationArchive study documentsArchive trial documentation and correspondence.Assess adverse reactionsAssess product quality issuesAssess quality process issuesAttend seminars, courses and meetings within and outside the companyAttend investigator meetingAttend seminarsBuild trial master file (TMF)Calculate timelines for conducting and completing the trialCoachCoach and provide guidance to clinical staff.Coach clinical staffCoach staffCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with project teamCollect patient forms and questionnairesCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorCommunicationComplete study proceduresConduct close-out visitsComplete case report form (CRF)Conduct literature searchesConduct maintenance visitsConduct studiesConduct site initiationConduct the trialEnsure good clinical practice (GCP)Follow up projectsInteract with ethics committeeInteract with pharmacistsInteract with physiciansInteract with regulatory stakeholdersMonitoring enrolmentQuality control processSchedule trial visitsSchedule sponsor monitoring visitsSolve problems

Education

  • Master in European Business, intensive general international management programme taught over 1 year across 2 countries. Master based on an MBA-style curriculum, programme accredited by AMBA from ESCP Europe Business School (1°st track in Turin, Italy Campus and 2°nd track in London, UK Campus) in 2016
  • Master in Management and Monitoring of Clinical Trials from EPHOS - School of PharmaStudies , Madrid-Spain in 2011
  • Master in Design, manufacture and testing of pharmaceuticals drugs from Salamanca University, Salamanca - Spain in 2010
  • PharmD in Pharmaceutical Sciences from Universidad Nacional Mayor de San Marcos, Lima-Peru in 2008
  • Bachelor in Pharmacy and biochemistry from Universidad Nacional Mayor de San Marcos, Lima - Peru in 2007

Training and Certification

  • “Coaching & Resilience” in 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Professional Proficiency
Spanish
Native
Italian
Elementary Proficiency
French
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Project Manager (CPM) Clinical Research Associate (CRA) Clinical Project Leader
  • Work From Home:
    Yes, 0 to 5 days per week
  • International:
    Yes

Area / Region

Madrid, Spain

Others

Driving License
  • Yes