Experience

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  Hospital general de catalunya

  Jan 1990 - Mar 1991

  Clinical nurse

  Nurse in the Gasrto-Intestinal Surgery Department

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  Chuv / centre hospitalier universitaire vaudois

  Jan 1991 - Jan 1992

  Registered nurse

  Nurse in the Internal Medicine Department

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  Chuv / centre hospitalier universitaire vaudois

  May 1993 - Jan 1994

  Critical care registered nurse

  Nurse in the Intensive Care Unit of Neurology

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  Almirall

  Mar 1995 - May 2015

  This was a more senior position I had in Almirall after 10 years of experience. This role involved these main activities:- Participate in the Medical subteams and Project Teams for discussion of the Global Development Plan and specifically about study designs.- Prepare and coordinate Request for Proposal for the selection of the CRO- Writing study protocols and study manuals- Reviewing key peroject documents such as Investigator's Brochure, briefing documents for Regualtory, DSURs, Statistical Analysis Plan and Clinical Study Reports.- Reviewing key operational and study specific documents such as technical sepcifications ( e.g spiromtreis, eCRF, ECGs, laboratories, IVRS, patient diaries...)- Ongoing review of blinded clinical data for identification of proocol deviations, to ensure accuracy of data cleaning and early detection of unexpected trends.- Preparation and participation on internal workshops- Preparation and participation on Investigator's meetings, CRAs and CROs kick-off meetings responsible for the training of the study protocol and study procedures. Mostrar menos I started working in Almirall as a CRA with the main responsibility of monitoring activities of clinical trials from phase I to phase IV. Involved in site's selection, site initiation visits, monitoring visits (I did one of the first remote data entry trial in 2000 in UK), close-out visits, design of CRFs and patient diaries, writing study manuals and monitoring guidelines and supervision of monitoring activities performed by CROs when these were outsourced through co-monitoring visits with CRAs from CROs. Mostrar menos

  • Senior Clinical Trial Manager

    Mar 2006 - May 2015

  • Principal Clinical Research Associate

    Mar 1995 - Feb 2006
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  Astrazeneca

  May 2015 - Jan 2017

  Senior manager clinical operations

  My current responsibilities include:- Lead multiple cross-functional global Clinical Study Teams for the AZ Barcelona Early Development portfolio, involving local and global AZ disciplines and external providers, from study set-up through to CSR delivery. - Key point of contact with the CRO study leader/project manager- Point of contact for the Japanese team from AZ KK for a phase IIb respiratory study.- Sole study management/operations responsibility for a respiratory project from study design concept through to CSR - Review, approve and follow-up the CRO and vendors budget ensuring all the trial deliverables are included in the trial cost and this is aligned with the program/trial cost approved by the AZ governance. Closely scrutinise budgets and timelines with many actions which lead to significant savings. - Write/review the trial essential documents such as clinical study protocols, ICF, technical specs for electronic systems, etc- Interface with Data Management representatives to facilitate the delivery of study data through the participation in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives- Interface with the AZ supply chain to facilitate Clinical Trial Supply delivery- Proactively manage project risks and constantly look for opportunities to reduce timelines and cost - Training and mentoring new members of staff within AZBC- Presentation of study results to the iPT and management meetings Mostrar menos

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  Allergy therapeutics

  Mar 2018 - Feb 2023

  Senior clinical study manager
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  Astrazeneca

  Mar 2023 - now

  Global clinical operations program director