Resumen profesional
Datos destacados
Experiencia
Formación
Enfatiza tus habilidades clave
Idiomas
Cronología
Receptionist
Paula Missart

Paula Missart

Resumen profesional

Soy una persona versátil, dinamica y proactiva, con muy buenas relaciones interpersonales. Poseo habilidades para la resolución de problemas, el trabajo en equipo y comunicación efectiva . Estoy abierta a nuevas oportunidades y desafíos donde pueda aportar mi experiencia, seguir aprendiendo y creciendo en este apasionante campo de la investigación clínica.

Datos destacados

12
12
years of professional experience

Experiencia

Local Medication Assistant

ICON PCL
Ciudad de Buenos Aires
03.2020 - Actual

Providing services for Janssen Cilag Farmacéutica S.A.

- Active role in trial start-up

- Local sourcing of authorized AxMP/NIMP: vendor management, sourcing, stock management, shipments to sites, etc.

- Liaison with Local Medication Depots

- Importation of IP, equipment, lab kits and supplies

- IP destruction

- Return of equipment to central vendors

- Support of local and central teams on supplies-related topics

- Post Trial Access programs: HA submission, importations, delivery to sites, stock management and resupplies

- Local Processes: Drafting of supplies-related local SOPs, training to local staff, SME feedback

- Responsible for preparing and submitting import license applications and extensions to ANMAT, ensuring compliance with regulatory requirements and timely approvals.

Sr. Clinical trial Assistant

ICON PLC
Buenos Aires, Ciudad Autonoma de Buenos Aires
05.2014 - 03.2020

Providing services for Janssen Cilag Farmaceutica S. A..

- Assistance with study start up and ongoing.

- Support and maintenance of paper and electronic files.

- Management of Advers events

- Preparing regulatory package

- Submission to the ethics committees

- Negotiating contracts

- Organizing research meetings

- Payment management


Sr. Clinical Trial Assistance

RPS RESEARCH S.R.L
Buenos Aires, Buenos Aires
06.2012 - 01.2014

Providing services for Sanofi S. A. - Genzyme Project

- Organization and maintenance of paper and electronic files (regulatory documents, financial contracts, databases).

- Financial support (receiving and paying invoices, budgets).

- Report preparation.

- Event organization.

- Support for monitors.

- IP and supplies management

Sr. Clinical Trial Assistance Star Up Unit

RPS Research S.A.
Buenos Aires, Buenos Aires
02.2012 - 06.2012

Providing services for Sanofi S. A.

- Responsible for preparing and submitting and follow up to initial package to the sites, Ethics Committees and MOH.

- Adaptation, review, negotiation, and monitoring of the Informed Consent approval processes with the Ethics Committees.

Sr Clinical Trial Assistance Start Up Unit

Activa CRO
Buenos Aires, Buenos Aires
07.2011 - 02.2012

Providing services for Sanofi S.A.

- Responsible for preparing and submitting and follow up to initial package to the sites, Ethics Committees and MOH.

- Adaptation, review, negotiation, and monitoring of the Informed Consent approval processes with the Ethics Committees.

Clinica Trial Assistant - MACO Unit

Sanofi S. A.
Buenos Aires, Buenos Aires
05.2008 - 07.2011

- Administrative support for the setup, monitoring, and reporting of clinical trials.

- Creation, management, and maintenance of files (regulatory documents, financial contracts, databases, import and export of investigational products, supplies, etc.).

Serious Adverse Events: distribution to investigators, Ethics Committees.

- Investigator payments. Report preparation, budgets.

- IVRS system.

- Supplies management (Stock management and distribution of IP, laboratory kits and supplies)



Formación

Tecnica Superior en Biotecnología - Orientación en -

ORT Argentina
/2003 - /2007

Enfatiza tus habilidades clave

  • Trabajo en equipo
  • Habilidad para aprender
  • Puntualidad y responsabilidad
  • Flexibilidad y adaptabilidad
  • Comunicación
  • Resolución de problemas
  • Organización
  • Persona proactiva
  • Habilidades sociales
  • Manejo del estrés

Idiomas

Inglés
Intermedio
B1

Cronología

Local Medication Assistant

ICON PCL
03.2020 - Actual

Sr. Clinical trial Assistant

ICON PLC
05.2014 - 03.2020

Sr. Clinical Trial Assistance

RPS RESEARCH S.R.L
06.2012 - 01.2014

Sr. Clinical Trial Assistance Star Up Unit

RPS Research S.A.
02.2012 - 06.2012

Sr Clinical Trial Assistance Start Up Unit

Activa CRO
07.2011 - 02.2012

Clinica Trial Assistant - MACO Unit

Sanofi S. A.
05.2008 - 07.2011

Tecnica Superior en Biotecnología - Orientación en -

ORT Argentina
/2003 - /2007

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CREAR PERFIL
Paula Missart