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Summary

My name is Ana Rita Delgado and I am Portuguese, moving to Brussels. I am a pharmacist, and I have been working in the clinical trials area since 2004. I start as a clinical trial assistant, moved to Clinical Research Associate (CRA), Lead CRA and now I am Clinical Project Leader and Country Champion. This last position is a specific position for the company I work for, mainly I do project management combined with a CRO, I am the face of the sponsor, in a study monitored by a CRO. As part of a small country in a Cluster environment, and with the most senior position within the unit, I am also acting as Country Leader, being involved in FTE management, SOP production and revision, Budget controlling.  I have been working in several therapeutic areas all over these years, mainly Cardiology, Central Nervous System, Diabetes, Rare Diseases, Diabetes and Oncology. I have also worked in pediatric trials.

 

Experiences

Current Experience

  • CSU Country Champion
    Since June 2012
    Main Sponsor contact in trials managed by a CRO. Liaison with CRO CRAs and PM involved in the project Health authorities submissions and contacts Involvement in site selection and final sites decision Involvement with National Coordinators and KOLs Weakly contacts with CRO CRAs for FU and input of activities needed Define local study budget Define strategies to boost recruitment and motivate sites Contacts with sites, being the “face” of the sponsor

  • Lead CRA
    Since July 2010
    Neurology (Multiple Sclerosis and Alzheimer disease trials) Rare Diseases Phase II to Phase IV Involvement in feasibility process for different areas / meetings with KOLs Locating and assessing the suitability of facilities at a study centre; Perform site selection visits and final site decision Perform CEC and HA submissions Perform study budget for the country Organization of National Investigators Meetings and participation in international Investig Meetings Country project management Participation in CRAs meetings Translation of regulatory document /protocol synopsis, inform consent Give training for all site team Involvement with National Coordinators and KOL Organization of site initiation visits Setting up the study centres, which includes ensuring each centre has the trial materials and training the site staff to trial-specific industry standards Monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV) collecting completed CRFs from hospitals and general practices Writing visit reports; Filing and collating trial documentation and report Ensuring all unused trial supplies are accounted for Closing down study centres on completion of the trial; To develop any necessary aids to allow studies to proceed expeditiously (e.g.newsletter, investigator flow charts) To maintain awareness of local regulatory requirements, and to conduct studies in accordance with IPC SOPs, guidelines and ICH Good Clinical Practice guidelines Work with the Safety Officers to clarify, respond to, and resolve adverse events as they arise To track study progress using study tracking tools, ensuring timely and quality updates to the system used o maintain effective communication with other members of the clinical team and management. Help with management of junior CRAs

Past Experience

  • Clinical Research Associate (CRA)
    July 2005 --- April 2011
    Main specialities of work: Cardiology, Neurology (Multiple Sclerosis, Alzheimer Disease, Stroke), Endocrinology, Internal medicine areas, Pedhiatric area, Orthopedy, Oncology.

  • IP Manager
    October 2004 --- July 2005

  • Clinical Project Assistant
    April 2004 --- July 2005

Knowledge

LinkedIn Assessment :
Clinical trialsPharmacoeconomicsDiabetesAlzheimer's diseaseGCPsPediatricsPharmaceuticsRare DiseasesSOPCardiologyNeurologyoncologyEndocrinologyPharmaceutical IndustryICH-GCPClinical monitoringTherapeutic AreasClinical researchGCPMultiple sclerosisClinical Site ManagementEnsaios clínicos

Education

  • in Farmacoeconomia from Ordem dos Farmacêuticos in 2010
  • in Pós Graduação Gestão de Marketing Farmacêutico from IDEFE in 2009
  • in Pharmaeutical Sciences from Instituto Superior de Ciências da Saúde-Sul in 2004
  • in Microbiology from Universidade Católica Portuguesa in 1998
  • in from Universidade de Lisboa in 0

Area / Region

Bruxelas, Bélgica

Others

Driving License
  • Yes