Regulatory & Start-up Specialist

• May 2023 - Present

Site Start-up and Regulatory Specialist (BEL, FRA, NLD)

• Sep 2021 - Apr 2023

- Preparation and submission of applications to regulatory authorities, ethics committees and other local authorities under the scope of the 3 countries regulations. Applications covered: from study start-up and initial submissions to End of Trial notifications, including substantial amendments, non-substantial amendments, periodic notifications and safety notifications - Regulatory advices and guidance for clients on submissions content and answers to authorities queries - Point of… Show more - Preparation and submission of applications to regulatory authorities, ethics committees and other local authorities under the scope of the 3 countries regulations. Applications covered: from study start-up and initial submissions to End of Trial notifications, including substantial amendments, non-substantial amendments, periodic notifications and safety notifications - Regulatory advices and guidance for clients on submissions content and answers to authorities queries - Point of contact between authorities, internal team and clients - Adaptation and review of Informed Consent Forms based on countries requirements - Maintenance of regulatory documents in the Trial Master File (TMF)

Clinical Trials Assistant at Syneos Health (previously Synteract)

• Sep 2017 - Sep 2021

Administrative management of clinical trial projects from start-up to close-out, in accordance with the standards of ICH-GCP, applicable local regulations and Standard Operating Procedures (SOPs). Main responsibilities include: -Set-up of the Trial Master File (TMF, paper and electronic) and Investigator Site Files -Maintenance of the TMF: filing, tracking, reports creation and distribution, follow-up with team, quality checks on content and completeness, support in case of audit… Show more Administrative management of clinical trial projects from start-up to close-out, in accordance with the standards of ICH-GCP, applicable local regulations and Standard Operating Procedures (SOPs). Main responsibilities include: -Set-up of the Trial Master File (TMF, paper and electronic) and Investigator Site Files -Maintenance of the TMF: filing, tracking, reports creation and distribution, follow-up with team, quality checks on content and completeness, support in case of audit, archiving -Management of various projects-related tasks: follow-up on team training, meetings, correspondence and newsletters, translations management, updates to trial-specific manuals -Support for set-up and maintenance of project databases -Support site identification and contact activities for feasibility projects -Management of site payments -Point of contact between team, sites, clients and vendors -Mentoring of new colleagues and interns, as well as Subject-Matter Expert on CTA responsibilities

Internship (clinical research)

• Jan 2017 - Feb 2017

Location: "Service de la Recherche Biomédicale" at Hôpital Erasme (unit gathering all the clinical research performed in the hospital). Tasks: -familiarization with regulatory documents and guidelines (declaration of Helsinki, ICH-GCP) -familiarization with the hospital accreditation (AAHRPP) -reviewing of Standard Operating Procedures -writing of visit forms for investigators, describing the procedures and measures to perform at each patient visit -encoding of patient data… Show more Location: "Service de la Recherche Biomédicale" at Hôpital Erasme (unit gathering all the clinical research performed in the hospital). Tasks: -familiarization with regulatory documents and guidelines (declaration of Helsinki, ICH-GCP) -familiarization with the hospital accreditation (AAHRPP) -reviewing of Standard Operating Procedures -writing of visit forms for investigators, describing the procedures and measures to perform at each patient visit -encoding of patient data into eCRF and Adverse event forms -observation of negotiations for contracts and budgets writing -observation of monitoring visits Show less Location: "Service de la Recherche Biomédicale" at Hôpital Erasme (unit gathering all the clinical research performed in the hospital). Tasks: -familiarization with regulatory documents and guidelines (declaration of Helsinki, ICH-GCP) -familiarization with the hospital accreditation (AAHRPP) -reviewing of Standard Operating Procedures -writing of visit forms for investigators, describing the procedures and measures to perform at each patient visit -encoding of patient data… Show more Location: "Service de la Recherche Biomédicale" at Hôpital Erasme (unit gathering all the clinical research performed in the hospital). Tasks: -familiarization with regulatory documents and guidelines (declaration of Helsinki, ICH-GCP) -familiarization with the hospital accreditation (AAHRPP) -reviewing of Standard Operating Procedures -writing of visit forms for investigators, describing the procedures and measures to perform at each patient visit -encoding of patient data into eCRF and Adverse event forms -observation of negotiations for contracts and budgets writing -observation of monitoring visits Show less

Internship

• Sep 2014 - Nov 2014

Internship performed during the master in chemistry, at the "Institut Scientifique de Santé Publique" in the laboratory responsible for the detection and analysis of Genetically Modified Organisms. Subject: development of a new method for the analysis of GMO by Polymerase Chain Reaction Internship performed during the master in chemistry, at the "Institut Scientifique de Santé Publique" in the laboratory responsible for the detection and analysis of Genetically Modified Organisms. Subject: development of a new method for the analysis of GMO by Polymerase Chain Reaction

Job student

• Sep 2012 - Jun 2013

Supervision of scholar groups from secundary schools at the "Expérimentarium de Chimie": explanation and popularization of the theoretical aspects, demonstration of experiments, monitoring of students during their practical part Supervision of scholar groups from secundary schools at the "Expérimentarium de Chimie": explanation and popularization of the theoretical aspects, demonstration of experiments, monitoring of students during their practical part

Job student

• Aug 2011 - Aug 2011

Restocking of the school furniture departement and help to the customers Restocking of the school furniture departement and help to the customers

Job student

• Aug 2010 - Aug 2010

Restocking of the school furniture departement and help to the customers Restocking of the school furniture departement and help to the customers