About Anais
I am a seasoned Medtech professional looking to support you with your Product Development, Clinical Validation & Scientific Communication objectives around Medical Devices. I owe a PMP certification in Project Management.
I can support you with:
I have expertise in following therapeutic areas: Electrophysiology, Interventional & Cardiac Surgery, Neuromodulation, Neurosurgery, Diabetes.
Looking forward to connecting!
French
Native or bilingual
English
Native or bilingual
Italian
Fluent
Can work on-site
London (up to 50km)
Experience
- ESPLORATIS MEDICALTechnical Project DirectorMEDICALJanuary 2024 - September 2024 (9 months)Rouen, FranceIn charge of New Product Development for a neurosurgical active implantable device.• Line management of the technical team: hiring, performance reviews, people management, resources & budget• Day to day project management, including timelines, budget & activity tracking• Status reporting to founding team, including KPIs and technical summaries• User needs elaboration with KOL neurosurgeons & translation to System requirements• Responsible for Design Control process & implementation• Supplier management• Pitching, participation to investors' search & fundraising activities
- MICROPORT CRMClinical Project ManagerMEDICALDecember 2018 - December 2023 (5 years)Paris, FranceIn charge of pre & post market international clinical trials for electrophysiology devices (cardiac pacing leads, pacemakers…).• Product validation roadmap & study design• Medical writing: scientific & regulatory (publications, congresses, Clinical Evaluation Reports…)• Preparation of study documentation (protocol, CRF & EDC, statistical report …)• Study oversight: coordination of +15 team members at European level• Day to day project management, including timelines, budget & compliance• Management of scientific committees and KOL surgeons• In charge of training and education for innovative products : workshops, proctoring…• Ad-hoc support for field activity (patient implantations and follow-ups, onsite visits)• Part of the product "Core Team": transverse work with R&D/Regulatory/Marketing/Operations for product development and full life cycle
- STENTYSClinical Project ManagerMEDICALOctober 2016 - November 2018 (2 years and 2 months)Paris, FranceManagement of international clinical program for coronary interventions• Strategic study planning• Preparation of study documentation (protocol, informed consent, CRF…)• Management of study start-up activities: site selection, regulatory submissions (EC/IRB)• On-site visits (initiation, monitoring, close-out), site trainings• Day to day management of studies, including timelines, budget & compliance• Safety management, Clinical Event Committee meetings• Data analysis, management of statistical analysis• Scientific writing (abstracts, study reports), material preparation for congresses• In charge of Clinical Evaluation process and maintaining Clinical Evaluation Reports• KOL management, input on local research initiatives from physicians• Clinical input for implementing global company strategy (product indications, regulatory submissions…)
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Education
- PMP CertificationPMI2024PMP Certification in project management
- Statistics applied to MedicineSorbonne Universités2019Interuniversity Degree – Statistics applied to Medicine
Skill set (13)
Categories
- Other