Experience

Debiopharm

• Switzerland
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Experienced clinical scientist

  • Aug 2023 - Present

  Lausanne, Vaud, Suisse



Servier

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Head of Clinical Scientist

  • Apr 2021 - Jun 2023

  Région de Paris, France

• Clinical Scientist

  • May 2017 - Dec 2022

  Région de Paris, France



GETAID

• Pharm D, Clinical trial project manager

  • Feb 2016 - Jan 2017

  Région de Paris, France Overall responsibilities for management of 5 studies (Phase IV, Phase III); from start up to publication. Regulatory Submission; ANSM, French Ethic committee. Bio banking: Organization of logistic, participated in contract negotiation for a bio bank Contract negotiation with sites eCRF design, Study Tools development Management of inspection of 2 sites by Belgian authorities Visits on site (initiation, closure, monitoring), Management of monitoring



Servier

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• pharmacien chef d'étude clinique

  • Mar 2013 - Jan 2016

  Servier From 2014 to 2015: Clinical support logistic Project manager Management of Central laboratories (contracts, set-up/follow-up/closure of activities, budgets, validation of essential documents). Review of SOPs aiming to start activities of newly created department. Training and management of team juniors From 2013 to 2014: Clinical trial manager Overall responsibilities for management of 1 study (Phase III); from start up to publication. Shared responsibility management of… Show more From 2014 to 2015: Clinical support logistic Project manager Management of Central laboratories (contracts, set-up/follow-up/closure of activities, budgets, validation of essential documents). Review of SOPs aiming to start activities of newly created department. Training and management of team juniors From 2013 to 2014: Clinical trial manager Overall responsibilities for management of 1 study (Phase III); from start up to publication. Shared responsibility management of 2 studies (PV of Phase IV study and co-management of phase 2 paediatric study). Design of essential documents (protocol, ICF, monitoring plan…) Design of scientific documents for regulatory Submissions (Europe). CRO (e-PRO, central lab, biobanking, Bio banking, material) : from request of proposal to closure of activities eCRF design, PV management (in collaboration with PV department) Preparation of statistical analysis (data blind review, validation of Statistical analysis plan).

• Pharmacien Chef d'étude clinique

  • Sep 2011 - Mar 2013

  Overall responsibilities for management of 1 study (Phase III); from start up to publication. Shared responsibility management of 2 studies (PV of Phase IV study and co-management of phase 2 paediatric study). Design of essential documents (protocol, ICF, monitoring plan…) Design of scientific documents for regulatory Submissions (Europe). CRO (e-PRO, central lab, biobanking, Bio banking, material) : from request of proposal to closure of activities eCRF design, PV… Show more Overall responsibilities for management of 1 study (Phase III); from start up to publication. Shared responsibility management of 2 studies (PV of Phase IV study and co-management of phase 2 paediatric study). Design of essential documents (protocol, ICF, monitoring plan…) Design of scientific documents for regulatory Submissions (Europe). CRO (e-PRO, central lab, biobanking, Bio banking, material) : from request of proposal to closure of activities eCRF design, PV management (in collaboration with PV department) Preparation of statistical analysis (data blind review, validation of Statistical analysis plan).