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Freelance
- Freelance Chef de Projets Cliniques
2019 - maintenant
• Freelance Chef de projets cliniques indépendant
• Ouvert aussi à de nouveaux postes dans l'industrie pharmaceutique ou à domicile (Lyon, Paris, Genève, Lausanne, Bâle)
• Chef de projets régional expérimenté, dans le secteur pharmaceutique, de la biotechnologie et des laboratoires centraux
• Compétences en pharmacie et biotechnologie, laboratoire central, sciences de la vie, gestion des CRO, opérations cliniques et système de gestion des essais cliniques (CTMS) et assurance de la qualité
• Solide professionnel en gestion de programmes et de projets, avec un Bachelors en sciences spécialisées en microbiologie et biochimie de l'Université du Pays de Galles, Cardiff, au Royaume-Uni
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ALTIZEM
- Quality Assurance Manager
Boulogne
2018 - 2019
- Gérer les non-conformités en collaboration avec le responsable du département et faire des analyses statistiques afin d’identifier très en amont les actions d’amélioration
- Relancer les équipes projets sur les actions correctives à mettre en place au niveau des non-conformités et des plan d’actions suite à audits
- Alerter sur les anomalies et veiller à leur résolution en collaboration avec le responsable assurance qualité et les équipes cliniques
- Rédiger et mettre à jour les SOP et documents associés, assurer leur traçabilité, et leur ventilation auprès des destinataires.
- Actualiser les systèmes et outils qualité en fonction de leurs évolutions
- Participer à la conception de méthodes et d'outils pour gérer la documentation qualité (gestion des AR des SOP, liste des documents qualité etc.)
- Vérifier les informations réglementaires dans les textes de loi et les réglementations spécifiques des pays impliqués dans les essais
- Veiller à la bonne application de la politique qualité et de la réglementation des essais cliniques par le suivi des rapports d’audits et plans d’actions qui en découlent
- Former et sensibiliser les équipes à l’assurance qualité et aux respects des BPC
- Proposer et participer aux projets qualité
- Répondre aux questions internes et externes concernant la qualité
- Participer à et piloter des projets transverses (outils, procédures)
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Covance Central Laboratory Services SA
- Regional Project Manager Europe-EMEA
2015 - 2018
• Act as local liaison between assigned Sponsor Representatives and the appropriate local CCLS platform
• Provide consultative approach in assessing the study local feasibility and set-up based on regional standard processes
and constraints
• Close collaboration with the Global Study Manager for all study related aspects that are pertaining to the
corresponding local platform and through all study stages, from setup to closure
• Partner with the assigned Global Study Manager to effectively monitor critical study milestones.
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Alizé Pharma-Lyon, France
- Clinical Project Manager Early Development
2013 - 2014
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Free Lancer
- Freelancer Project Manager/Clinical Research Associate
2009 - 2012
Responsible for Project Management and monitoring of Clinical Trials in various therapeutic areas in different CROs or Pharmaceutical companies in Greece.
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CRO Coronis Research S.A, Athens, Greece
- Clinical Trials Project Leader, Clinical Operations
2007 - 2009
I led and managed the Clinical Operations team. Managed a team of Clinical Research Associates and Clinical Trial Assistants. I was responsible for agreed areas of projects' strategy, set priorities, KPIs for Team/Unit and individuals. Seek resources, delegate to project teams, monitor and evaluate the project process and outcomes. Responsible for Clinical team management and reporting of activities, budget management and customer service. Overall responsibility for Clinical Operations team, seek to identify and develop new business opportunities.
Main objectives/tasks.
Overseeing the planning, implementation and administration of clinical trials, ensuring compliance with the sponsor’s requirements, ICH/GCP guidelines, applicable SOPs, associated legislation and regulatory requirements
Supervision of CTAs, CRAs and Sr CRAs in their function of in-house and onsite clinical monitoring activities, which included work allocation, training and problem resolution
Setting departmental objectives, establishing deadlines and ensuring that targets were consistently met.
Identifying nonconformity of subordinates with applicable SOPs and recommending and implementing corrective and/or preventive action
Communicating with Legal, Regulator y and Safety, Medical and Scientific Affairs and Business Development Departments to ensure all time lines were met
Facilitating investigator and site selection
Ensuring that all employees within the clinical department were adequately trained and oriented
Providing advice and solutions to clients regarding any aspect of clinical operations
Tracking study budget
Preparing invoices according to contractual terms
Facilitating communication of project status and coordinating of project task completion with the Sponsor and Data Management Department
Monitoring actual versus contracted performance on an ongoing, proactive basis
Monitoring appropriate resource allocation (individual, study/projects)
Maintaining regular interface with regulatory authority staff
Providing support to the Chief Operations Officer (COO) and Managing Director for Business Development issues
Supporting the conduct of internal system or site audits by Coronis QA and other respective bodies and/or inspections by the respective Competent Authorities (National or Other) in the scope of the project
Representing the company to clients, clinical investigators, contractors and consultants
Key achievements.
Successfully completed projects ahead of time and within the budget
Successfully identified troubleshooting and risks and successfully prevented them
Established a highly motivated and cross business/client team relationships
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UCB PHARMA Grèce/Belgique
- Medical Scientific Advisor
2005 - 2007
Managed the operation of the Medical Scientific Unit, setting targets against KPIs meeting targets, and objectives, medical marketing and customer service, budget responsibility. I had a coordinating and supervisory role in Clinical Operations (Clinical Trials projects) and built a strong and direct collaboration with sales and marketing teams.
Main objectives/tasks.
Identification of key stakeholders and clients developed an effective communication plan to ensure key messages were given. With special focus on healthcare professionals in key areas of business
Coordination and follow up in conducting clinical trials (Phase III, IIIb, IV, retrospective and non-commercial)
Supervision of medical writing and statistical analysis of data of these trials
Establishment of strong relationships with selected healthcare professionals
Set up communications chain for the dissemination of scientific information / product messages through a variety of events and also organise these events in some cases., e.g. National and International Congresses, Advisory Boards, Local Meetings, Presentations, Investigator Meetings.
Developed and organised Scientific Training of the Sales Force team
Identified and developed a communications/promotion programme for the introduction of new product information
Strong collaboration with company’s headquarters in Belgium
Key Achievements.
Successfully liaised with Key Opinion Leaders, establishing business plans. And a CRM to support the brand.
Successfully coordinated the local Marketing and Sales teams with the Medical content, producing high quality detailing and training materials and development of brands promotional and communication material. Reconfigured the team and introduce flexible ways of working, as well as cost saving in terms of staffing
Supported and offered medical advice to internal and external customers on brand and provided medical training to marketing and Sales Teams.
Successfully designed, organised and coordinated local and international clinical trials cooperation with Global Medical Department
Successfully demonstrated outstanding people leadership capabilities, cross functional expertise, experience and ability to work in a highly complex and matrix environment.
Successfully demonstrated strategic and analytical thinking expertise, as well as ability to influence senior management decision making,
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ROCHE PHARMA-GRÈCE
- Clinical Research Associate
1999 - 2005
Responsible for monitoring and implementing local and international Clinical Trials according local and international strategy.
Main objectives/tasks.
Management of clinical trials in the therapeutic areas of Hepatitis C and B (Phase III and IV)
Conduction of clinical trials according to Standard Operating Procedures and Good Clinical Practice
Supervision of finance and logistics of clinical trials
Collaboration with different departments in various countries
Usage of specialised computer programs / databases for the management of the clinical trials
Organising of meetings with key opinion leaders of Virology therapeutic area
Supervision of statistical analysis of trials data
Key Achievements,
Successfully monitored and managed local and international Clinical Trials
Successfully collaborated with different Investigators and Clinical staff at sites and Marketing and Global Clinical operations teams.
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JANSSEN PHARMA-GRÈCE
- Sales Representative
1995 - 1999
Responsible for boosting sales in Hospital and Private sector in Athens and other territories in Greece.
Main objectives/tasks.
Present and sell company products and services to current and potential clients.
Prepare action plans and schedules to identify specific targets .Follow up on new leads and referrals resulting from field activity.
Identify sales prospects and contact these and other accounts as assigned.
Prepare presentations, develop and maintain sales materials and current product knowledge.
Establish and maintain current client and potential client relationships.
Manage account services through quality checks and other follow-up.
Identify and resolve client concerns.
Prepare a variety of status reports, including activity, closings, follow-up, and adherence to goals.
Communicate new product and service opportunities, special developments, information, or feedback gathered through field activity to appropriate company staff.
Key Achievements.
Successfully increased sales
Successfully identified sales prospects and opportunities in private offices and Hospitals in my territory.
Developed the sales team into an effective sales force and build internal relationships with company staff to accomplish the work required to close sales.
Develop and implement special sales activities to reduce stock.
