Experience

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  Farmacia virgen del rocio

  Jul 2013 - Oct 2013

  Clinical staff pharmacist
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  Hôpital saint-antoine

  Oct 2013 - Apr 2014

  Hospital pharmacist

  − Analysis and validation of prescriptions at hospital environment in order to be able to choose the best treatment based on haematology test.− Observed medical surgeries.− Daily visits of patients regarding the service to evaluate progress or possible after-effects.

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  Pharmacie de l' île saint louis

  Jun 2014 - Dec 2015

  Pharmacist

  − Autonomous team manager.− Dispensing of prescriptions and advising of patients.− Stock control.− Parapharmacy courses.

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  Cesif

  Jan 2016 - Jul 2016

  Master in clinical trials and medical affairs
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  Inventiv health clinical

  May 2016 - Sept 2016

  Clinical research associate (cra) trainee
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  Syneos health clinical solutions (previously inc research/inventiv health)

  Oct 2016 - Nov 2018

  Clinical research associate on behalf of novartis

  − Perform site either on-site or remote visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and complete appropriate documentation.− Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations.− Evaluate overall performance of site and site staff.− Interpret data to identify protocol deviations or major risk to data integrity.− Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines.− Generate queries and manage resolutions with site personnel.− Perform investigational product accountability as per the protocol and Study Monitoring Plan− Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.− Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.− Monitor patient safety, identify and address any protocol deviations.− Obtain, review and process regulatory and administrative documents from investigator sites.− Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations. Show less

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  Syneos health (previously inc research/inventiv health)

  Nov 2018 - Oct 2019

  Clinical research associate ii on behalf of novartis

  − Perform site qualifications, site initiation, interim monitoring and close-out visits ensuring regulatory and protocol compliance. Visits may be performed on-site or remotely.− Review completion of proper informed consent procedures.− Ensure accurate data reporting via review of site source documents and medical records.− Interpret data to identify protocol deviations and risks to subject safety/data integrity.− Generate queries and manage resolutions with site personnel.− Perform investigational product accountability as per the protocol and Study Monitoring Plan.− Evaluate execution of study protocol at the site level. Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.− Obtain, review, and process essential regulatory and administrative documents to ensure completeness, accuracy, and regulatory compliance.− Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.− Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing variables to achieve goals / targets.− Act as primary liaison with study site personnel.− Enter data into tracking systems as required.− Participate in the identification and selection of investigators and clinical sites.− Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.− Provide clinical and technical support for project team as required.− May interact with representatives of client affiliates as per project requirements. Show less

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  Novartis

  Oct 2019 - now

  The Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development studies in compliance with Novartis processes and regulatory requirements.The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies.- Study & Site Operations strategy- Initiation and conduct of trials- Delivery of quality data and compliance to quality standards- Budget and productivity Show less

  • Clinical Project Manager

    Aug 2023 - now

  • Clinical Site Expert

    Aug 2022 - Aug 2023

  • Clinical Site Associate

    Oct 2019 - Sept 2022