Sibi Rébecca LAWSON

En résumé

Entreprises

• Lawson ClinExell - Clinical Research Consultant

  2017 - maintenant Health is a gift which requires excellence in care for any human being, provided that diseases target their prey indiscriminately.
  Human beings are still not equal facing access to appropriate healthcare and medical treatments. Medical needs remain unmet in some areas of the globe.
  
  Lawson ClinExell was founded in 2017 by Sibi Rébecca Lawson, to be an active and major partner for Global Health improvement.
  
  Our company offers clinical research consultancy services to actively support drug development in emerging markets in addition to western countries in close collaboration with clients from non-profit organizations, academy, start-ups, biotechnological and pharmaceutical companies on ambitious, challenging and innovative global clinical projects.
  
  We provide a range of services adapted to our clients needs which covers various aspects of clinical trial management, monitoring oversight and quality management support in respect of their timelines, resources and budget requirements.
  
  Our mission is to set up a distinctive partnership with each of our clients and provide them with hands-on, customized and high quality trial management services towards success.
  
  For further information, please visit our website: https://www.lawsonclinexell.com or contact us: lawson@lawsonclinexell.com

• Vectura - Clinical Trial Manager

  Toulouse 2015 - 2017 Responsible for the implementation of phase I/II clinical trials (20-600 patients) in EU within the disease area of Asthma/COPD
  Collaboration with VP of Clinical Development department on clinical development plans: clinical trial designs, literature search, budget assumptions, vendors assessment.
  Collaboration in development, writing and review of essential documents: IB, protocol, IMPD and risk management plan
  Identification and selection of external providers (CRO, Central lab, IRTS, Spirometry vendors) from full set-up to management
  Collaboration in corporate compliance: process improvement and GCP quality management

• Actelion - Trial Manager

  Paris 2013 - 2014 Responsible for the implementation of a phase II clinical trial in 16 countries (78 patients), 40 sites (AAP, Europe and America) within the disease area of Chronic Thrombo Embolic Pulmonary Hypertension.
  Ensure studies conduct in compliance with GCP, internal SOPs, local regulatory guidelines, protocol, EC and RA approvals
  Collaborate proactively with all key stakeholders to ensure timely deliverables within budget
  Responsible for selection and management of external providers (CRO and IRTS): full set-up and budget management.

• Chuv Centre Hospitalier Universitaire Vaudois - Clinical Study Manager

  2012 - 2013 Responsible for the execution of phase I clinical trials (40-100 patients) within the disease areas of AIDS, tuberculosis, influenza (vaccines)
  Ensure that clinical trials are conducted in accordance with local regulations, Good Clinical Practice, and internal procédures
  Collaborate in preparation of protocols, CRFs, essentials documents, SOPs, Quality Management Plan
  Manage the accurate distribution of study drugs / the shipment of specimen and blood samples to local laboratory
  Implement recruitment strategies: pre-screening, informations sessions, visits scheduling and enrolment tracking
  Contribute to the public communication strategy

• NovImmune - Clinical Operations Manager

  2011 - 2012 Responsible for execution of observational and phase I clinical trials within the disease area of hematology and orphan disease (HLH)
  Responsible for developing the clinical operations department in collaboration with the Head of Clinical Operations
  Management of external providers (CRO, CMO, local laboratory)
  Perform accurate ordering and distribution of clinical trial supplies
  Create and/or review clinical documentation: laboratory manual, monitoring plan, site guidelines, SOPs

• Actelion - Clinical Trial Manager

  Paris 2009 - 2011 Responsible for the execution of a phase II and III clinical trials (40-1200 patients) in Scandinavia, France and Australia within the disease area of pulmonary artery hypertension
  Participate to the clinical trial plan in terms of operational aspects
  Collaborate proactively with all key stakeholders to ensure timely deliverables within budget
  Provide guidance and training to regional team (15 regional managers and associates): lead site management activities, communicate of actions plans and recruitment strategy, perform accompanied visits, review and approve site visit reports
  Create, review and approve essential documents and study-specific documentation
  Responsible for direct task and budget management of external providers
  Responsible for site audit preparedness, coordinate CAPA

• INC Research - Lead/Clinical Research Associate

  2006 - 2009 Lead site management activities in Europe (Belgium, Germany, France and The Netherlands): Visits reports approval, proactively collaborate with global lead CRA to ensure trial conduct in adherence with GCP and quality standards
  Clinical sites management for phase III studies (8-10 sites / 1500-3000 patients) within the disease area of infant pneumococcal meningitis and Age Macular Degeneration : feasibility, site selection, initiation, monitoring and close-out visits in France and Switzerland

• Université De Sherbrooke - Research Associate

  Sherbrooke 2004 - 2005 Coordinate research projects in neurosciences (Pain)
  Develop experimental protocols in collaboration with life science team
  Manage laboratory supplies
  

• IPS Therapeutique Inc. - Quality Assutrance Manager

  2003 - 2004 Manage QA department in compliance with FDA standards
  Create/update internal standard operating procedures
  Audit research activities and supervise personnel (3 technicians)
  Present QA program to clients

Formations

• Université De Sherbrooke (Sherbrooke)

  Sherbrooke 2003 - 2004 MSc Pharmacologie
  
  Pharmacologie

• Université Paris 7 Denis Diderot

  Paris 1999 - 2000 DEA Biologie et Pharmacologie cutanées
  
  Biologie et Pharmacologie cutanées - «PRIX DUCRAY RECHERCHE» Laboratoires Dermatologiques DUCRAY - Congrès Annuel de la Recherche en Dermatologie, Bruxelles, Belgique - Mai 2001

• Université Paris 7 Denis Diderot

  Paris 1996 - 1999 Licence de Biochimie
  
  Biochimie - Application aux industries Pharmaceutiques - Programme d’échange ERASMUS (Université de Stockholm, Suède)

Réseau

• Alexandra RIDEAU

• Atlan PATRICK

• Bintou CISSÉ

• Cécile KILEDJIAN

• Imen JELASSI

• Johanna NGO KOBE

• Laëtitia CHOPIN

• Samia HOUARI

• Yannick GALLIN

• Yvon BADRONE