Clinical Project Manager - Neurology

• May 2022 - Present

Proposal Development Manager for clinical trials

• Jun 2021 - May 2022

Subject of study: Neurology, Oncology, Immunology • Budgets preparation for clinical studies including project management, samples analytical testing services, data management and logistics • Business development support through delivery of high-quality and detailed budget proposals within given timeframe • Analysis of requests for proposal coming from pharmaceutical and biotech companies • Project feasibility assessment to ensure that scientific, technical, regulatory, and operational aspects meets business needs • Liaison between customers, global business development teams and global operational teams throughout budget proposal generation • Development of relationship with existing and potential customers • Organization and coordination of kick-off, budget presentation, strategy, capabilities and bid defense meetings • Follow-up of budget proposals progress until awarded • Participation in price setting process and maintenance of price book • Development of custom tools using VBA programming language to facilitate budget proposals generation Show less

Clinical Project Manager

• Jul 2019 - Jun 2021

Subject of study: Oncology (head & neck, breast, colorectal, bladder cancers and cerebral metastasis) • Coordination of clinical trials logistical aspects from set-up to closure in accordance with regulatory and contractual requirements • Establishment of the study timelines • Follow-up of milestones and deliverables in compliance with quality and timelines • Pivotal point of contact for the study team, pharmaceutical companies and vendors • Organization and leading of meetings • Management and follow-up of the studies budget • Redaction of protocols, Informed Consent Forms (ICFs) and other study related documents • Coordination of Investigational Medicinal Product (IMP) supplies with manufacturers and Contract Research Organizations (CROs) • Selection and management of various vendors • Selection of investigational sites in collaboration with the study team and preparation of the recruitment projections • Preparation of dossiers for ethic committees and competent authorities submissions • Report of risks or issues that could jeopardize studies and implementation of corrective actions in conjunction with the study team • Maintenance of the Trial Master Files (TMFs) • Participation in the department development by suggestion/implementing new tools or internal processes • Contribution to the selection of candidates and interview process for Clinical Trial Assistant position and training of new team members Show less

Clinical Project Manager

• Aug 2018 - Jul 2019

Subject of study: Post-Traumatic Stress Disorder - REMEMBER study ("Longitudinal study in brain imaging, neuropsychology and psychopathology on the consequences of a traumatic event") Clinical Project Management: • Project management and budget follow-up for the clinical study • Team coordination (scientists-in-charge, clinical study techniciens and investigators) • Exchanges with participants and stakeholders • Investigator study file (ISF) maintenance • Precedures (SOP) and Good Clinical Practices (ICH-GCP) monitoring and teaching to the new staff members • Eligibility critera and (Serious) Adverse Events follow-up • Developing the eCRF template Scientific research: • Application for funding for the REMEMBER study • Scientific writing • Analysis of the preliminary results of the study Show less

PhD Student in Neuroscience

• Jun 2014 - Dec 2017

Subject of study: Visual information processing in the early visual system • Contribution to the project from the experimental design and the data acquisition to the analysis and publication of the results • Analysis and statistics of large datasets using custom-written scripts • Scientific articles writing (one research article and one review) • Presentation of scientific results at five international conferences (in Europe and USA) • Supervision of master students Methods: • State-of-the-art two-photon calcium/glutamate imaging • Electrophysiology • Immunohistochemistry • Data analysis • Programming • Statistics Poster presentations at international conferences: • Göttingen Meeting of the German Neuroscience Society (2015 and 2017) • European Retina Meeting in Brighton (2015) and Paris (2017) • Federation of American Societies for Experimental Biology (Retinal Neurobiology and Visual Processing) in Kesytone (2016) Others: • Planning and designing collaborative Research & Development projects • Interdisciplinary and international team work • Scientific presentation and scientific writting • Hard-skills course (programming, neurophysiology, statistics) • Soft-skills course (effective paper writing, time and project management) Show less

Research Assistant in Neuroscience

• Sep 2013 - Apr 2014

Subject of study: Functions of neuronal network in the pituitary gland • Establishment of a challenging technic in the laboratory (confocal imaging combined with optogenetic) in collaboration with engineers • Validation of the new technic on different preparation (cell culture and sliced tissue) Methods: • Calcium imaging • Optogenetic • Cell culture • DNA sequencing Subject of study: Functions of neuronal network in the pituitary gland • Establishment of a challenging technic in the laboratory (confocal imaging combined with optogenetic) in collaboration with engineers • Validation of the new technic on different preparation (cell culture and sliced tissue) Methods: • Calcium imaging • Optogenetic • Cell culture • DNA sequencing

Internship in a Neuroscience Research Laboratory

• Jan 2013 - Jul 2013

Subject of study: Duchenne muscular dystrophy • Combined three different approaches to correlate functional and anatomical modifications in mouse model of Duchenne muscular dystrophy (ex-vivo and in-vivo imaging, and immunohistochemistry) Methods: • Immunohistochemistry • Confocal microscopy • Electron microscopy reconstruction • Optical coherence tomography (OCT) • Angiography Subject of study: Duchenne muscular dystrophy • Combined three different approaches to correlate functional and anatomical modifications in mouse model of Duchenne muscular dystrophy (ex-vivo and in-vivo imaging, and immunohistochemistry) Methods: • Immunohistochemistry • Confocal microscopy • Electron microscopy reconstruction • Optical coherence tomography (OCT) • Angiography