Freelancer profile translated to English.
Back to original languageAbout Naima
I offer services in clinical studies and pharmacovigilance:
Clinical data entry and vigilance:
Query resolution, Narrative redaction and vigilance case entry
Administrative also
Experience: 5 years
deadline compliance
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 50km)
Experience
- aphp ,cro,unicancerClinical Research Associate / Clinical Trial AssistantMEDICALFebruary 2019 - Today (7 years and 4 months)-Management of industrial, academic, and retrospective studies (Phase II, III, and IV)-Database implementation-Constitution, monitoring, and regulatory and administrative registration-Deadline compliance-Archiving-Preparation of summaries and reports-Preparation of training and communication documents-Scientific, medical, and regulatory watch-Reception of vigilance cases-Declaration/Notification SAE, EIG / EI safety easy monitoring-Duplicate detection, vigilance case entry, MedRa coding-Resolution of Queries, deviations, Request form-Staff training-Creation and updating of enrollment dashboards, e-CRF and TMF management-Remote monitoring, randomization, enrollment log-Management and processing of pre-analytical biological samples (centrifugation)-Conducting questionnaires and tests-Sample ordering, preparation of shipment-Management of sponsor/CRO, competent authorities follow-ups-Verification of dispensing of units-Proficiency in software: Office Suite, Ennov, Safety Easy, I-medidata, Coptis, Redcap....
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Certifications
- ICH-GCP E6(R2)ICH-GCP E6(R2)2023
Skill set
Categories
- Other