BrightOwl Loader Loading

Summary

Pharmacy Degree and Master in Medical Science Liaison with deep knowledge of Good Clinical Practice (GCP), involved in international clinical trials conduction, including rare diseases trials and experienced in several therapeutic areas. Relevant knowledge and experience in other Pharmaceutical Industry areas: Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), dispensation and commercialization. Enthusiastic and proactive person with big curiosity on innovations who likes to investigate and discuss them with others, who is used to work with people covering diverse roles in several scenarios. Able to communicate by training or dissemination sessions to entry level people as well as by maintaining fluid discussions with experts. Motivated by challenging projects and capable to quickly adapt to them. Team player who feels comfortable and works effectively in multidisciplinary teams and who can assume leadership responsibilities in a natural manner.

Experiences

Past Experience

  • Medical Science Liaison ( MSL ) Master
    September 2016 --- April 2017

  • Senior Clinical Research Associate (CRA)
    June 2014 --- June 2016
    Perform either on-site or remote site visits and monitoring activities in accordance with protocol and GCP guidelines. Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations. Interpret data to identify major risks to data integrity or any protocol deviations and make appropriate recommendations. Use expertise and judgement to identify and resolve complex site issues and deficiencies. Understand project scope, budgets, and timelines and manage project objectives to meet timelines. Participate in the identification and selection of investigators and clinical sites. Assist in the development of study procedures and guidelines. Interact with representatives of the Sponsor. Mentor junior staff on training, guidelines, and processes. Therapeutic Areas (diseases): Neurology (Multiple Sclerosis), Cardiology (Pulmonary Arterial Hypertension).

  • Clinical Research Associate (CRA)
    February 2007 --- May 2014
    Conduct on-site Visits (Pre-Study, Initiation, Monitoring and Close-Out)and prepare accurate and timely trip reports. Site management responsibilities. Undertake feasibility work and recruitment of potential investigators. Prepare Ethic Committees submissions and notifications to regulatory authorities. Negotiate contracts and study budget with sites. Assist with training, mentoring, and development of new employees. Support the project management team with clinical trial activities as required. Act as a Local Project Coordinator with the sponsor, investigational sites and study vendors. Therapeutic Areas (diseases): Cardiology (Acute Coronary Syndrome, Hypercholesterolemia), Ophthalmology (Diabetic Macular Edema), Oncology (Liver Cancer, Multiple Myeloma), Urology (Hyperactive Bladder), Infective (Influenza), Nephrology (Dialysis).

  • Owner of a retail shop
    September 2003 --- January 2007

  • Chief of Quality Assurance
    November 2000 --- August 2003
    Responsible for the Quality Team working performance. Responsible for the company GMP training program. Conduct Internal Audits. Technical representative of the company in audits and inspections.

  • Inspector - Departamento Inspecciones I.NA.ME.
    April 1997 --- November 2000
    Inspect several types of companies with health-related activities to verify GMP and national regulations.

  • Chief of Quality Control
    January 1997 --- March 1997
    Validate analytical and microbiological quality control methods. Technical representative of the company.

  • Pharmacy Technician
    March 1990 --- March 1997
    Assist in medicines dispensation, prescripted compound forms preparation and commercial activities.

Personality

Self Assessment :
CollaborationDiligenceFlexibilityInnovative thinkingInterest in knowledgeOptimismProactivityProblem solvingResponsibilityStrategic thinkingWillingness to compromise

Knowledge

LinkedIn Assessment :
Industria FarmacéuticaMedical Science LiaisonÁreas terapéuticasEnfermedades RarasNeurologíaCardiologíaOncologíaOftalmologíaBuena práctica clínicaClinical researchEnsayos clínicosClinical trialsFarmacovigilanciaBiotecnologíaBiotechnologyCiencias naturalesCaptura de datos electrónicaEDCeTMFCTMSIVRSConsentimiento informadoICFSistema de gestión de ensayos clínicosBuenas prácticas de fabricaciónOrganización de investigación por contratoInvestigación clínicaAsuntos normativosDesarrollo clínicoEsclerosis MúltipleSíndrome de EisenmengerHipertensión Arterial PulmonarEdema Macular DiabéticoSíndrome Coronario AgudoInfarto Agudo de MiocardioHipercolesterolemiaMieloma MultipleBig DataArtificial IntelligenceGood Clinical Practice (GCP)Medical affairsCross Functional Team BuildingDrug DevelopmentCRO managementMarketing StrategyPharmaceutical IndustryoncologyTherapeutic AreasNeurologyCardiology

Skills and Expertise

Self Assessment :
Analytical skills Build and manage the Trial Master File (TMF) Create SOPs Guide students Interact with nurses Interact with physicians Monitor a clinical study Search literature on clinical trialsAct as the main line of communication between the sponsor and the investigatorAdminister, maintain and co-ordinate the logistical aspects of clinical trialsApprove patient informationAssess quality process issuesAssess site feasibilityAssess subject safetyAttend investigator meetingAssist with site trainingCoach clinical staff

Education

  • Medical Science Liaison (MSL) Master in Pharmaceutical Industry from Talento Farmacéutico in 2017
  • Pharmacy Degree in from Universidad de Buenos Aires in 1997

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Spanish
Native

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Medical Science Liaison (MSL)
  • Locations I am interested in:
    Madrid, Spain
  • Work From Home:
    Yes, 1 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
    BrightOwl employee :    100% FTE
  • International:
    Yes

Area / Region

Madrid, Spain

Others

Driving License
  • No