Freelancer profile translated to English.
Back to original languageAbout Prasanthi
🎯 To support you in the operational, regulatory, budgetary, and qualitative implementation of your preclinical and clinical studies (RWE, RIPH 1 to 3 clinical trials) in order to bring well-being to a larger number of patients.
🌏 Neurology / Metabolic Pathologies / Food Supplement
📝 * Design, Writing and Execution of
-> all documents related to clinical studies according to international regulatory requirements (EMA, ICH-GCP, FDA, ISO) and preclinical studies
-> any other type of Medical-Scientific and educational material intended for a wide range of audiences
* Conduct literature reviews of studies and participate in scientific watch
* Management, Analysis and Valorization of your research data
📗🗣️💡 * Patient Education
* Scientific Advice
* Health & Prevention Information
French
Native or bilingual
English
Fluent
Tamil
Native or bilingual
Can work on-site
Paris (up to 50km), Toulouse (up to 50km), Rennes (up to 50km), Strasbourg (up to 50km), Lille (up to 50km)
Experience
- Institut Neurologie APHP Pitié SalpêtrièreClinical Research OfficerMEDICALJanuary 2019 - May 2025 (6 years and 4 months)Paris, France-> Investigator Clinical Research Associate Missions*
- Coordinate and Ensure the smooth running of participant inclusion and follow-up visits
- Detection and reporting of SAEs/SUSARs to pharmacovigilance or materiovigilance•
- Collection and management of data in the eCRF (RedCap, CleanWeb)
- Management of biological samples• Database management (ORBIS, BaMaRa)
-> Clinical Research Project Manager Missions- Lead the operational, regulatory, budgetary, and qualitative implementation of RWE clinical studies and RIPH 1 to 3 clinical trials according to international regulatory requirements (EMA, ICH-GCP, FDA, ISO)
- Medical-scientific writing of documents related to clinical studies (protocol, CRF, information sheet, consent form, investigator brochure, SOP, recruitment poster, and other documents required for submissions to various regulatory authorities (CPP, ANSM, CNIL))
- Monitoring of research agreements with institutional partners in France and abroad
- Design and management of databases with CDMS tools; eCRF (RedCap, CleanWeb)
- Analyze, Interpret and Valorize clinical data
- Evaluate research protocols in terms of feasibility
- Study budget management
- Coordination of reference center missions (writing activity reports (PIRAMIG), labeling) and representation of the center at various events (Rare Disease Day, AMADYS patient association)
- EA4466 PRETRAM – Laboratoire de Biologie de la Nutrition, Université Sorbonne Paris CitéFundamental and Preclinical Research Officer.MEDICALJanuary 2017 - January 2019 (2 years)Paris, France
- Writing of documents related to fundamental and preclinical studies
- Evaluate research protocols in terms of feasibility
- Analyze, Interpret and Valorize clinical data
- Conduct literature reviews of studies and participate in scientific watch
- Respond to calls for projects
- Budget and logistics management•
- Supervision of interns with guidance for writing theses and oral presentations
- Département de Physiologie_UNILClinical Project ManagerMEDICALJanuary 2016 - October 2016 (9 months)Lausanne, VD, Switzerland
- Patient screening, management of inclusion and follow-up visits
- Collect clinical study data on a CRF
- Composition of foods based on nutritional and caloric intake to create optimized menus
- Measurement of energy expenditure using indirect calorimetry
- Conduct literature reviews of studies and participate in scientific watch
- Writing of documents related to clinical research (protocols, SOPs, consent forms, recruitment forms)
- Ensure compliance with deadlines and budget
- Writing of documents related to scientific publication and communication (abstracts, posters, PowerPoint presentations, scientific articles)
- Submit scientific articles
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Education
- Post-DoctoratPost-Doctorat
- Doctorat en Nutrition et Métabolisme CliniqueUniversité Sorbonne Paris Cité2015Doctorat en Nutrition et Métabolisme Clinique
Certifications
- Clinical Research Project ManagerSorbonne Paris Cité University2016
- Clinical Data ManagerAbsilon2024