Hélène Devroye Email and Phone Number
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Accomplished professional with extensive experience leading high-profile clinical projects, fixing any reliability issues, tracking service metrics, managing large-scale budgets. Adept at ensuring efficient execution of multiple projects by allocating resources and co-ordinating with team members. Skilled in implementing operational improvement initiatives and providing strategic directions to obtain anticipated results. Instrumental in heading and mentoring cross-functional teams by implementing dynamic leadership approaches to achieve desired outcomes.• 10+ years experience in Clinical Research• Study Management : Phase I to Phase III• On-site monitoring oversight visits• Trial Master File reviews• Regulatory sunbmission overview• Vendor oversight• Clinical Supply• Data Management
Convert Pharmaceuticals
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Clinical Research ConsultantAkontio Sep 2019 - PresentAs a freelancer, I worked for several companies such as the European Society of Anesthesiology and Intensive care (ESAIC), Convert pharmaceuticals and the Akkermansia company. I like to work for smaller companies where there is always a new challenge to take on.
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Clinical Development ManagerConvert Pharmaceuticals Sep 2020 - PresentLiège, BeAdvise and coordinate with management team on the clinical development plan and competitive intelligence strategies.Lead all aspects of project management operations from inception to completion withinbudgetary and time constraints for the Phase I/Ib study.Implement best industry practices to ensure safety and well-being of the patients as well as quality and reliability of data.
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Animatrice FédéraleLes Scouts Asbl Jun 2022 - PresentBruxelles, Be -
Equipière FédéraleLes Scouts Asbl May 2020 - Jun 2022Bruxelles, Be
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Clinical Project ManagerConvert Pharmaceuticals Sep 2018 - Sep 2019Liège, BeLead all aspects of project management operations from inception to completion withinbudgetary and time constraints for the Phase I/Ib study.Implement best industry practices to review of study related documentation, including clinicalstudy protocol investigator’s brochure and IMPD. Execute diverse range of activities such asclinical, central labs, data management, statistics, and medical writing. Co-ordinate with seniorsto formulate new clinical positioning and competitive intelligence strategies.
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Product Team LeaderBone Therapeutics S.A. May 2017 - Jun 2018Mont-St-Guibert, Walloon Region, BeLeading the Product Teams to provide a product focused approach that integrates all functions, enhances communication, enables governance and ensures team ownership of product development.Objective:- Provide a clear Product focused approach with a well-defined product strategic vision in line with company strategy and functions- Deliver project in line with Target Product Profile (TPP)- Enable full time supervision, guidance and monitoring of product development operational activities- Enable for special projects within the process of product development- Defines a product focused governance in line with existing governance- Enables communication of relevant information to all stakeholders -
Clinical Study ManagerBone Therapeutics S.A. Jul 2016 - Jun 2018Mont-St-Guibert, Walloon Region, BeMain activities include : • Coordinate study-related activities for Phase III clinical study• Writing and review of study-related documentation: Protocols, Case Report Form, Investigator Brochure, Informed Consent Form, Standard Operating Procedures, Study Procedure Manuals... • Perform Ethics Committees' submission• Help build the strategy for patients recruitment • Participate in site selection and initiation visits• Manage activities and interactions with CROs• Ensure adherence to protocols and procedures• Supervise monitoring activities and logistical aspects of the clinical trial
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Professeur InvitéHepn - Haute Ecole De La Province De Namur Jan 2015 - Jun 2017Namur, Namur, BeTerminologie médicale en langue anglaise dans la catégorie économiqueAnglais spécifique dans la catégorie paramédicale -
Senior Project ManagerB&C Group Jan 2015 - Jun 2016Mont-St-Guibert, Walloon Brabant, Be• Coordinate projects under his/her responsibility effectively across the operational departments• Design and implement solutions to answer customer’s request• Provide operational input and design solutions for projects to the Sales Executive• Act as primary contact and final responsible person between the customer and the B&C operational departments to ensure customer satisfaction• Ensure that B&C services are delivered on time, within budget and according to the agreed quality standards• Assign and check work related to projects under his/her responsibility• Take part in the overall improvements of internal processes and systems• Keep an eye on industry innovations that may be used to improve B&C processes and systems -
Project Coordinator ProductionB&C Group Feb 2013 - Jan 2015Mont-St-Guibert, Walloon Brabant, Be- coordinate studies/projects effectively within the production department- ensure that B&C services are delivered on time, on budget and to agreed quality standards- act as key interface and final responsible person between the customer and the B&C operational department
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Project ManagerBusiness & Decision Life Sciences Dec 2009 - Jan 2013Evere, Brussels Region, Be• Coordination of CDISC SDTM conversion projects• Liaison with clients• Set-up and planning of the project activities in collaboration with the project team.• Ensure the project team complies with all applicable SOPs and sponsor agreements• Management of the project team with regard to the project work.• Set-up and management of resource requirements for assigned projects• Generation of proposals• Budget monitoring• Follow-up of Timelines -
Cdash Team MemberCdsic Feb 2011 - Dec 2012
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Data Integration SpecialistBusiness & Decison Feb 2009 - Dec 2009Creation of CDISC STDM Conversion DefinitionCreation of Define.xmlQC of mapping tables, STDM datasets and metadata
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Data Manager4Clinics Aug 2007 - Jan 2009I was responsible for the cleaning of the clinical database at GSK Biologicals : • Run automatic checks to identify inconsistencies in the clinical database • Generate and review data queries • Assure the completeness, the accuracy and the consistency of all data in the clinical database • Do the reconciliation with external lab data
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Clinical Safety AssociateSgs May 2007 - Aug 2007Process data and write narratives in the Safety databaseVerify the accuracy, the completeness and the consistency of the data
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Mathematic TeacherIpes Seilles Nov 2005 - Jun 2006
Hélène Devroye Skills
Hélène Devroye Education Details
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Université Catholique De LouvainBiomedical Sciences -
Université De NamurMedicine
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Institut Saint Berthuin
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Ulg
Frequently Asked Questions about Hélène Devroye
What company does Hélène Devroye work for?
Hélène Devroye works for Convert Pharmaceuticals
What is Hélène Devroye's role at the current company?
Hélène Devroye's current role is Freelance Clinical Research Consultant and Clinical Development Manager @Convert Pharmaceuticals.
What is Hélène Devroye's email address?
Hélène Devroye's email address is he****@****outs.be
What schools did Hélène Devroye attend?
Hélène Devroye attended Université Catholique De Louvain, Université De Namur, Institut Saint Berthuin, Ulg.
What skills is Hélène Devroye known for?
Hélène Devroye has skills like Cro, Clinical Trials, Data Management, Clinical Research, Clinical Data Management, Cdisc, Project Management, Gcp, Lifesciences, Pharmaceutical Industry, Ich Gcp, Clinical Development.
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