Experience

Venn Life Sciences - part of hVIVO plc

• United Kingdom
• Research
• 1 - 100 Employee

• Consultant clinical pharmacokinetics

  • Jun 2020 - Present



AIXIAL GROUP

• France
• Research Services
• 400 - 500 Employee

• Clinical Project Manager

  • Jan 2018 - May 2020

  - Management of international studies in order to ensure respect of timelines and budget and quality of data and analysis. - Lead and help cross-functional team (Site Management, Monitoring, DM, Stat, Pharmacovigilance and Medical Writing) to deliver qualitative results on time - Promote active listening, win-win approach and effective client feedback process - International study set-up: create protocol, ICF, Diary Card, Study Site Manual, CRF completion guideline, Monitoring Plan and assemble Core Package - Oversee the study progress and keep the team and the management up to date - Bid defense participation - Management of feasibility - Management of submissions to ECs and CAs - Management of vendors (IMP management, central lab): planning, budget, activities - Implementation of the CTMS within the team and training of translational teams - Main point of contact with the sponsor and link with translational teams and subcontractors Show less



Biotrial

• France
• Research Services
• 100 - 200 Employee

• Clinical project manager

  • Jan 2017 - Dec 2017

  - Develop study protocol and create related study documentation for Phase 1 studies- Improve the effective coordination of cross-functional team, including medical writing, biometry and internal Phase 1 clinical team.- Management of submissions to ECs and CAs.- Lead and help cross-functional team (external Monitoring, CTA, DM, Stat, Pharmacovigilance and Medical Writing) to deliver qualitative results on time- Main contact for client communication

• Clinical pharmacokineticist

  • Nov 2011 - Dec 2017

  PK expertiseAdvices for conception and redaction of protocols for PK studiesReview of statistical analysis plan in cooperation with statisticiansPerformance of non-compartmental PK analysisOn-line analysis for dose escalation meetingsDevelopment and review of PK study reports (CSR) and interim PK reportsPrimary client liaison for PK concernsReview and writing of PK proceduresPerforming internal PK trainingTherapeutic areas & study phases: Mainly Phase I and II studies on various therapeutic areas (Oncology, Virology, Neurology…)Other Activities:• Junior pharmacovigilance officer• Coding (MedDra)• Junior Phase I pharmacist Show less

• Non-clinical quality assurance officer

  • Nov 2011 - Sep 2015

  -Management of internal and external audit-Performance of quality assurance training on GLP-Involvement in AAALAC accreditation-Redaction and application of procedures in compliance with GLP.-Support for the integration of preclinical pharmacology unit in new facilities and carrying out experiments involving non-human primates.-Putting into practice and monitoring new regulations



Servier

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• trainee in non-clinical pharmacokinetic

  • Oct 2010 - Jun 2011

  -Development and evaluation of one mouse PBPK model to test antineoplastic drugs -Bibliographic research and internal PK training -Integration of mouse physiological characteristics in the PBPK model -Validation of the model with reference drugs -Software : WinNonlin, AsclXtrème. -Development and evaluation of one mouse PBPK model to test antineoplastic drugs -Bibliographic research and internal PK training -Integration of mouse physiological characteristics in the PBPK model -Validation of the model with reference drugs -Software : WinNonlin, AsclXtrème.



BASF beauty care solutions

• Région de Lyon, France

• Trainee in regulatory affairs and toxicology

  • May 2010 - Sep 2010

  Implementation of the new regulation REACH Introduction of toxicology bibliographic records and validation of safety data sheets Implementation of the new regulation REACH Introduction of toxicology bibliographic records and validation of safety data sheets



CHU d'Angers

• Angers

• Trainee

  • Sep 2009 - May 2010

  Internship at the Hospital Pharmacy, clinical trial unit (3 months) Internship at the Clinical Service of Nephrology (3 months) Internship at the Toxic -Vigilance and Poison Control Centre (3 months) Internship at the Hospital Pharmacy, clinical trial unit (3 months) Internship at the Clinical Service of Nephrology (3 months) Internship at the Toxic -Vigilance and Poison Control Centre (3 months)



Université de pharmacie

• Région de Regensburg, Allemagne

• Erasmus trainee

  • Jun 2008 - Sep 2008

  Subject: Production and cellular exploration of nanoparticules: the Quantum dots Subject: Production and cellular exploration of nanoparticules: the Quantum dots