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Summary

· Advanced knowledge and eight years of clinical trials experience in several departments, as Regulatory and Start-up, Clinical Operations, Data Management and Administration of several Contract Research Organizations. · Experienced Regulatory and Start-up Specialist. · Advanced knowledge of GCPs. · Proven effective written and oral comunication skills. · Ability to work effectively as a part of a team or individually. · Multilingual: Bussines level in English, Spanish and Catalan. Intermediate level in German. · Hard-worker and dedicated, focused always in obtaining the best quality in all tasks performed. · Extensive multi-task working experience.

Experiences

Current Experience

  • Start-up Specialist
    Since April 2015
    · Develop and maintain knowledge of global and local regulatory requirements and industry practice/guidelines for submission activities · Manage the preparation of the local documentation for the submission package (Country Informed Consent Form and any other documentation given to patients) · Manage activities associated with obtaining initial and amended central authority approvals i.e. Ministry of Health, Central Independent Ethics Committee (IEC) and any other authorities including: - determining requirements for central County specific submissions and approvals - collecting the documentation for the submission package from relevant parties - preparing/revising any Country specific documentation as required - ensuring that the documentation submitted to the central authority complies with Country requirements, GCP, the trial protocol and any other applicable requirement - submitting the required information/documentation to the central authority and facilitating collection, response and resolution of feedback of any questions received - following-up the submission process until approval for the clinical trial has been obtained - collecting approval/acknowledgment of the trial as required in the Country - filing submission documents, authority correspondence, approval/acknowledgments in the Trial Master File and also to the eTMF - notifying to the central authorities of study closure or other updates as required · Manage contract negotiation/execution/payments with site/investigators/other parties involved as per applicable regulations, procedures and Sponsor/site requirements · Maintain tracking of regulatory, ethical and administrative authorizations · Ensure project team members (including Sponsor) at local and global lever are fully informed of project status, timelines, and issues for submission activities · Update regulatory database or information system with required data on the study activation process

Past Experience

  • Regulatory and Start-Up Specialist
    November 2013 --- April 2015
    - Serve as Single Point of Contact in assigned studied for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management. Ensure adherence to standard operating procedures, work instructions, quality of designated deliverables and to project timelines. - Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. - Prepare site regulatory documents, reviewing for completeness and accuracy. - Ensure accurate completion and manteinance of internal systems, database and tracking tools with project specific information. - Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. - Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP release documens, in line with project timelines. - Amendment submission to Regulatory Authorities, update status of amendments to the project team. - Amendment submission to Ethical Committees, update status of amendment to the project team. - Amendment to Clinical Trial Agreements.

  • Sr Clinical Trials Assistant - Regulatory and Start-Up maintenance coordinator
    January 2013 --- November 2013
    · Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance with timelines. · Collaborate with CTL on the preparation, handling and distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness. · Collaborate with CTL on the preparation, handling, and distribution of Clinical Trials Supplies and maintenance of tracking information. · Assist with the tracking and management of Case Report Form (CRFs), queries and clinical data flow. · Act as a central contact for the clinical team for designated project communications, correspondence and associate documentation. · Assist in training and orienting new staff. Act as a mentor for less experienced CTAs. · Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required traning and with required approval. · Perform assigned administrative tasks to support team members with clinical trial execution. · Regulatory and Start-up Maintenance coordinator. · Amendment to Clinical Trials Agreements. · Perform Regulatory, Start-Up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. · Prepare site regulatory documents, reviewing for completeness and accuracy. · Payment Group member, perform payments to investigators (more than 100 sites at same time), high knowledge and interpretation of Clinical Trial Agreements and budgets.

  • Clinical Trial Assistant
    July 2010 --- December 2012
    · Assist Clinical Research Specilist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance with project timeliness. · Assist the clinical team in the prepartion, handling and distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard opreating procedures. Assist with periodic review of study files for completeness. · Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handlinh and distribution of Clinical Trial Supplies and maintenance of tracking information. ·Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. · Act as a central contract for the clinical team for designated project communications, correspondence and associated documentation. · Accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval. · Perform assigned administrative tasks to support team members with clinical trial execution.

  • Clinical Trial Assistant / Executive Secretary / Administrative Department
    January 2008 --- March 2010
    · Assist the clinical team in the prepartion, handling and distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard opreating procedures. Assist with periodic review of study files for completeness. · Assist CRS/iCRS, CRAs/iCRAs and RSU with preparation, handlinh and distribution of Clinical Trial Supplies and maintenance of tracking information. ·Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. · Act as a central contract for the clinical team for designated project communications, correspondence and associated documentation. · Redaction, perparation and review of annual reports, follow-up reports and clinical study reports. · Maintence and update of Data Bases. · Customers service phone line. · Preparation and maintenace of standard operating procedures (SOPs). · Creation and maintenace of work instructions and templates.

  • Environmental Reporter
    July 2007 --- December 2007
    · Environmental reporter of the Asian tiger mosquito (Aedes albopictus) surveillance programme · Home visits reporter. Follow-up visits. · Follow-up of incidents reaching the Customer Services. · Management and maintenance of the Data Base. · Technical and administrative support to coordinator's programme.

Knowledge

LinkedIn Assessment :
CTMSClinical trialsRegulatory submissionsPaymentsContract negotiationRegulatory DocumentationGCPICH-GCPICH guidelinesCTACROData entryData ManagementAsuntos normativosBuena práctica clínicaCaptura de datos electrónicaControl clínicoDesarrollo clínicoEnsayos clínicosGestión de datosNormas ICH de buenas prácticas clínicasOncologíaOrganización de investigación por contratoSistema de gestión de ensayos clínicosRegulatory affairsInvestigación clínicaIndustria Farmacéutica

Education

  • Technical Engineering in Computer Systems in Ingeniería informática from Universitat Oberta de Catalunya in 2015
  • Centro López Vicuña in Healthcare Documentation and Codification Technician from Centro López Vicuña in 2006
  • Healthcare Documentation practices in from CAP Maragall. ABS Congrés. Barcelona. Spain. in 2006
  • Licentiate degree in Biotechnology from Universitat Autònoma de Barcelona in 2002

Area / Region

Barcelona, Spain

Others

Driving License
  • No