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Cristina Costa Noguera

Site Management Associate Ii @Veristat

San Fernando de Henares, ES
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2023 — Present

Site Management Associate Ii @Veristat

Madrid, ES

Provides centralized, administrative and technical support to the project team(s) and Investigator Sites. A critical member of the Clinical Operations team at large, offering continuity and serving as a liaison across departments and project teams. A pivotal point of contact between the Investigator Site and the project team ensuring effective and efficient delivery of Site Activation through to Site Close Out in accordance with applicable Veristat Policies, Standard Operating Procedures (SOPs), conventions and instructions set out by the Project Director or Project Manager, as well as current Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and applicable local regulations. Maintains a constant line of communication with the CRA and other cross functional departments to ensure site activities are compliant with ICH‐GCP and approved Project Plans.

EDUCATION

N/A

Spanish, French, English, German

Central School of Languages - Madrid

N/A

High School Madrid

GSE Degree A levels Sciences

N/A

Goethe Institut Madrid

German

SKILLS

Pharmaceutical IndustrySopRegulatory AffairsRegulatory SubmissionsCROClinical MonitoringIch-GcpGcpClinical DevelopmentSoftware DocumentationEdcCtmsManagementOncologyPharmacovigilanceClinical TrialsClinical Research

ABOUT CRISTINA COSTA NOGUERA

Spanish, English, French, German. Skills:Strong attention to detail, excellent communication, leadership, open minded, committed, easy going, optimistic, team builder, organization and prioritization.Experience in Clinical Trials.Management of eTMF (Veeva Vault), Rave, Files Reviews, ECs, MOH, Collection and QC of Essential Documents, MVs, ISFs. Audits, Inspections. Meetings, Call meetings. Vendors, Invoices, Payments, Trackers, Trainings, CRF Queries, Database Lock.Used to work with PMs-CTMs- CRAs. Multicultural teams.Study Phases I- Therapeutic areas/diseases: Gene therapy, Hematology, Oncology, Neurology, Pediatrics, Respiratory, Digestive, Pain, Multiple Sclerosis, Sleep Disorders, Sepsis, Alzheimer, rare diseases, COVID vaccines.Based in Madrid, open to relocate within Europe.

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