Experience

STALICLA

• Switzerland
• Biotechnology Research
• 1 - 100 Employee

• Clinical Trial Manager

  • Oct 2021 - Present

  - Planning, set-up and management of international clinical studies (Autism Specturm Disorder) in accordance with the contractual timelines, deliverables and with the applicable Standard Operating Procedures - Development of study documents (protocols, informed consents, patient facing documents, study plans) - Identification and management of vendors (Clinical Operations, Central Laboratory, Data Management, Safety Management etc.) - IRB/EC submissions - Sites identification, selection and conduct of the study in close collaboration with them - Study budget overview Show less



Edwards Lifesciences

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Lead CRA

  • Sep 2020 - Sep 2021

  - Field monitoring of studies and data collection for clinical trials as site’s responsible or as supervisor of CRO/CRA Contractors - Keep clinical trial/study subject documentation within parameters of study hypothesis, as well as monitor clinical trial/study safety, in keeping with protocols, Good Clinical Practices and relevant regulatory requirements - Review monitoring visit reports of CRAs and provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff and to study site management - Identify and report adverse events and device-related complications in accordance with regulatory and internal requirements with the support of the Safety team - Verify trial/study data, including maintaining appropriate regulatory documents both internal (eTMF) and external (ISF), auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded Show less



CERC (Cardiovascular European Research Center)

• France
• Think Tanks
• 1 - 100 Employee

• Lead CRA

  • May 2019 - Aug 2020

  - Monitoring activities oversight- Training and mentoring of junior CRAs (accompanied visits)- Management of Adverse Events and Clinical Events Committees- Management of international and national studies on Medical Devices; support to Clinical Project Manager- Preparation of study documents and support to Regulatory Submissions

• Clinical Research Associate

  • Nov 2017 - Apr 2019

  - Monitoring activities (on site and remotely) in cardiology in different European Countries- Site activities follow-up for small national studies to multicentric, international, prospective, large randomized trials- Management of the quality (ISO 13485, ISO 9001, Standard Operating Procedures)



AdBiostat

• Paris Area, France

• Clinical Research Associate

  • Mar 2017 - Oct 2017

  Observational study (medical abortion), medical device study (dermatology) and national phase III study (rheumatoid arthritis) -monitoring and close-out visits -report writing -phone calls -logistical follow-up -TMF management -project leader support Observational study (medical abortion), medical device study (dermatology) and national phase III study (rheumatoid arthritis) -monitoring and close-out visits -report writing -phone calls -logistical follow-up -TMF management -project leader support



INSERM

• France
• Research Services
• 700 & Above Employee

• Independent Researcher

  • Oct 2012 - Aug 2016

  Project leader in biochemistry/molecular biology. Elucidation of the molecular mechanism of senescence driven by S6 kinases. Project leader in biochemistry/molecular biology. Elucidation of the molecular mechanism of senescence driven by S6 kinases.



Université de Fribourg - Universität Freiburg

• Switzerland
• Higher Education
• 700 & Above Employee

• Research assistant (PhD)

  • Feb 2008 - Sep 2012

  PhD in biochemstry. Regulation of TOR Complex I (TORC1) and cell growth by amino acids in S. cerevisiae PhD in biochemstry. Regulation of TOR Complex I (TORC1) and cell growth by amino acids in S. cerevisiae



Tetrahedron SAS

• France
• Food and Beverage Manufacturing
• 1 - 100 Employee

• Ingénieur de Recherche

  • Oct 2005 - Dec 2007

  Purification and quantification of natural compounds with bioactive potential. Screening of a chemolibrary with potential anti-tumoral activity. Protocol settings following literature search. Purification and quantification of natural compounds with bioactive potential. Screening of a chemolibrary with potential anti-tumoral activity. Protocol settings following literature search.