more than 10 years expertise in Clinical trials (from clinical and operational prospective). strong understanding of patient/customer's needs and expectations. strong experience in Problem Solving and Planning of activities and deliverables Communication Skills developped and improved on an ongoing basis. high expertise in Coaching and Training active participation to improvement projects in the different functions.
Clinical Supply Manager
Since October 2013
Project Management of imp supply for assigned Clinical trials: - plan, coordinate and communicate clinical supply activities to optimal quality, time and budget. - manage the complete imp Supply Chain for assigned studies. - manage the set-up, maintenance, return/destruction and archiving of assigned multi-national phase 1-4 trials (through delegation to clinical supply associates when deemed appropriate): - drive strong partnership with stakeholders, participate in trial team meetings as a liaison for cts. educate and influence as needed, to ensure optimal incorporation of cts input into decisions impacting the imp Supply Chain - review and contribute to Clinical Trial science)" rel="nofollow">Protocol development with regard to regulatory and GMP requirements, cmc issues and cts aspects. - design imp through Translation of the science)" rel="nofollow">Protocol into Packaging and labeling requirements, ensuring a proper balance between technical feasibility, optimally designed clinical presentation, and Compliance with all applicable regulations. - define and consolidate an imp supply and distribution Strategy to ensure adequate and sufficient Forecasting of drug product, comparators, and final imp - set-up and write core label text documents and coordinate the country label text translations and regulatory approval process. - achieve planned milestones regarding clinical supply related trial set-up activities including Packaging, labeling, irt requirements/specification development, distribution, and return/destruction. - lead operational kick-off meetings with relevant functions , to share study information, collect input on Packaging design and timelines, and agree on the trial project plan. - monitor drug product and imp inventory quantities and expiry dates. - present imp information at Investigator meetings. - plan and monitor cts trial budget, and communicate any required adjustments to other functions Project Management of IMP supply for assigned clinical trials: - Plan, coordinate and communicate clinical supply activities to optimal quality, time and budget. - Manage the complete IMP supply chain for assigned studies. - Manage the set-up, maintenance, return/destruction and archiving of assigned multi-national Phase 1-4 trials (through delegation to Clinical Supply Associates when deemed appropriate): - Drive strong partnership with stakeholders, participate in trial team meetings as a liaison for CTS. Educate and influence as needed, to ensure optimal incorporation of CTS input into decisions impacting the IMP supply chain - Review and contribute to clinical trial protocol development with regard to regulatory and GMP requirements, CMC issues and CTS aspects. - Design IMP through translation of the protocol into packaging and labeling requirements, ensuring a proper balance between technical feasibility, optimally designed clinical presentation, and compliance with all applicable regulations. - define and consolidate an IMP supply and distribution strategy to ensure adequate and sufficient forecasting of drug product, comparators, and final IMP - Set-up and write Core Label Text documents and coordinate the Country Label Text translations and regulatory approval process. - Achieve planned milestones regarding clinical supply related trial set-up activities including packaging, labeling, IRT requirements/specification development, distribution, and return/destruction. - Lead Operational Kick-Off Meetings with relevant functions , to share study information, collect input on packaging design and timelines, and agree on the trial project plan. - Monitor drug product and IMP inventory quantities and expiry dates. - Present IMP information at Investigator Meetings. - Plan and monitor CTS trial budget, and communicate any required adjustments to other functions
Clinical Supply CoordinatorApril 2012 --- October 2013
plan, coordinate and communicate the Clinical Trial supply activities (phase 1-4 Clinical trials): - review of the clinical study protocols with regard to Clinical Trial supplies (cts) aspects (good Manufacturing practices, regulatory requirements, etc…). - design finished investigational medicinal product (imp) through Translation of the science)" rel="nofollow">Protocol into Packaging and labelling requirements. - creation of study manuals for handling of imp: Pharmacy manuals (describes Packaging, distribution, storage and preparation of imp), return manual. - provide Training to cras on drug handling - present the cts information at the Investigator meeting. - coordination of an optimal distribution Strategy of imp. - contribute to the ivrs specifications by defining the requirements for imp related functions. - work with the Outsourcing group for cts outsourced activities, approve invoices and monitor trial specific cts budget. - cts key Member in trial team meetings. - interactions with various functions in an international environment: Pharmaceutical Development, analytical, Quality Assurance, Qualified Person, Regulatory Affairs (global & affiliates), Biostatistics, Clinical Development, global medical affairs, external contract Research organisation, ivrs, vendors. - monitor drug product and imp inventory and expiry date. - define and consolidate imp supply Strategy.
Drug Supply CoordinatorApril 2010 --- April 2012
after developing a new Procurement)" rel="nofollow">Supply Management system, integrated the tema in charge of the logistical coordination of the Clinical Trial @ gsk Vaccines wavre. attendance to relevant meetings (Packaging, Randomization, ...) helicopter view on the project to avoid issues --> Problem Solving. discussion with the Planning team. Training and Coaching of the newcomers. discussion ont he further implementation of the system.
Logistical Projet Coordinator (CRC)April 2008 --- March 2010
Consultant at gsk biologicals support and coordination to the development of a new demand and supply request application. adapt SAP application to business requirements; compare system proposal and adapt them to business needs; discussion with relevant experts in impacted department; review of asis processes and review the impacts of the new system identify, update and write sops deal with Planning and timelines Validation meetings with users on regular basis preparation of implementation Planning preparation of the further implementation phase of the project coordination of key users activities support to development of user guide and Training material
Clinical Trial Assistant (CTA)November 2002 --- July 2005
preparation of submission dossier to Ethics committee (following eu specification); preparation, tracking and qc of study related documents; new eu directives for Clinical trials : reading and summary of relevant elements of the document, Training of the department members, direct application to ec submission ; Logistics : Planning and reservation shipment, tracking of materials expiry dates, ordering and re-supply of material qc of the shipment, preparation of the related Documentation (letter, pro forma invoice) ; Document Management: customization of document following sponsor's specific requirement review of the documents ordering of the number of exemplars needed Quality Control of study specific documents tracking of the mandatory documents archiving of study files study mails compilation qc and approval of suppliers invoice; Internet Research : emea and FDA guidance and regulations; reading of new sops and presentation to the team (summary of the relevant point via e-mail); office support to department members : summary and explanation of the most common function used; phone contacts with suppliers, sponsors and clinical centres; organisation of business trips; organisation of meeting (room and meals); minutes of meeting compilation; centralisation of the holidays : Planning setup;
Project/Management SecretarySeptember 2001 --- October 2002
documents setup; mails and submission compilation; data compilation ; power point Presentations filing of the submission dossier; centralisation of the holiday request and update of the related file; trip booking; meeting organisation (meeting room booking, meals, . ) office supplies order ; phone contacts with customers, sub-contractors ; update of the Marketing documents ;
SecretaryJuly 2001 --- August 2001
contacts with customers ; mail compilation; documents and presentation setup; hotel and trip booking.
Trainee in secretarial tasksSeptember 2000 --- January 2001
mail compilation ; aqr compilation and setup; phone contacts ; meeting organisation: meeting room, meals booking, setup of the meeting room; mail filing end distribution; supplies order.; Trainee in secretarial tasks - campaert n.v. phone contacts with French speaking customers checking and preparation of delivery Planning; mail compilation.; Trainee in secretarial tasks - aquapro sprl checking of suppliers invoices and payments from customers; mail filing; shipment order; material and office supply order ; setup of a mailing presentation to customers; monitoring of the public call submission,
AdaptabilityIndependenceInterest in knowledgeOptimismOrganizationProactivityProblem solvingSelf-disciplineService orientedTrustFlexibilityEfficiencyAnalytical thinkingAssertivenessAttention to detailCollaborationCoordinationCreative thinkingCritical thinkingCuriosityDiligenceWillingness to compromise
Skills and Expertise
Build and manage the Trial Master File (TMF) Analyze data Control data Create SOPs Report data Use content management systemsAdjust processes Approve drug supply Approve Label Master SheetBuild trial master file (TMF)Calculate trial timelinesCoachCollaborate with project teamCommunicate with sponsorCoordinate logisticsCreate SOPsCreate study documentsDevelop ICH/GCP compliant processesDevelop software programsDevelopment of Pharmacy manualDistribute trial suppliesForecasting of drug productForecasting of packaging workloadInteract with CROsInitiation visitManage clinical trial files/documentsManage study budgetManage study supplyManage trial master file (TMF)Oral presentationOrganise meetingsPlanning clinical studiesProvide input to process improvement initiativesProvide trainingRegulatory documentationRegulatory submissionsSet up a clinical studySupervise trial supplies
Master in Human Resource Management (evening from ISC Saint-Louis in 2005
Graduate; ère candidature in Office Management (Management and Administration); Communication from ECSEDI in 2000
Master for foreign people in History, history of arts from Universidad complutense Madrid in 1996
Certificate d'étude secondaire in option Langues from Institut Saint-Joseph in 1995
Training and Certification
CRA 1 (CROMSOURCE) in 2010 Training
Negotiation in 2007 Training
6sigma yellow belt in 0000 Certification