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Alexandre WEILLER

Durham

En résumé

Travaillant actuellement au sein de la société Quintilès (entreprise spécialisée dans la recherche clinique), mon rôle consiste à gérer et à planifier les activités opérationnelles de 7 études afin d’atteindre les objectifs fixés par le client. D'une part, je suis très impliqué dans l’accueil et la formation des nouveaux arrivants sur mes différents projets et ce, afin de créer rapidement une dynamique d’équipe. D'autre part, je garde quelques activités opérationnelles en participant à la gestion quotidienne des bases de données (processus de ‘cleaning’ de la base de données, édition de queries, implémentation des corrections), en étant engagé dans des activités de migration (définition et paramètres des contrôles de cohérence, création et validation des ‘test cases’) sur deux plateformes, Oracle RDC et Medidata Rave, et en exportant des données pour l'analyse.

Mes compétences :
Esprit d'équipe
Communication
Curiosité et sens de l'innovation
Qualité
Compréhension des informations
patience

Entreprises

  • Quintiles - Clinical Data Manager

    Durham 2012 - maintenant Study team Lead experience on complex studies, from set up to lock:
    - Management of DM metrics (number of queries in all status, number of missing pages, number of missing visits, number of missing signatures)
    - Plan goal priorities and review of timelines in accordance to the customer and all stakeholders. Distribution of the work to the DM team by managing time and priorities
    - Management of quality procedures : get sure all team members has been well trained and signed a training transcript, get the insurance that the Standard Operating Procedures are available
    - Ensure data system compliance by following guidelines of international regulatory authorities and internal policies
    - Participation to process review and amelioration : creation of tips and of new tools
    - Financial reports review every month, and management of workscope if additional activities requires additional budget
    - Management of communication with the customer and with people included in the project (CTH, TDM, Statistician, CMM, safety) by having Data review meetings and by using emails.


    Clinical data management activities within clinical projects, including:
    - Train and follow up of offshore staff (India, China, South-Africa): training on operational activities as data entry, query generation and resolution. Management of the team work quality (7 to 10 members)
    - Study documents review: review of the study protocol, of the non-eCRF data, of the data transfer specification, of the data transfer guidelines and of various guidelines (coding, SAE reconciliation, local lab).
    - Creation of eCRF and checks, implementation of User Acceptance Tests

    Data validation activities (as a Validation team lead):
    - Validation of eCRFs by testing if all pages are correct and in the right order
    - Validation of checks by creating test cases and by the creation of test patients
    - Edition of queries, implementation of correction manually or automatically
    - Ensures by making control quality tests if the quality data collection techniques are established
    - Reconciliation of various data by comparison between the third vendor data and by data present in the database (SAE reconciliation, third vendor reconciliation as, Imaging reconciliation) : management of external providers
    - Support to CRAs by helping them using the database and by asking them completing missing data and by training them in order they can help PI to answer queries

  • Transgene - Internship in Data management/CRA (Transgene, Illkirch – Graffenstaden).

    Illkirch Graffenstaden Cedex 2012 - 2012 Discover of various aspects of clinical research by managing a Phase I study with few patients:
    - Clinical Research Associate Tasks : New sites monitoring included in the study, train of the staff, explanation of the goals and of the study needs.
    - Clinical Data Manager tasks : Organization and follow-up of clinical trials, creation of observation books, creation of databases, edition of queries, implementation of correction, creation and validation of checks, internal and on-site data quality control.
    - Activities of pharmacovigilancy: Collection, follow-up and statement of the SAE.

  • Laboratoire WELEDA - Préparateur de commandes

    HUNINGUE 2011 - 2011 Préparation de commandes selon la formule galénique.

  • Institut de Bactériologie - Stagiaire en laboratoire de recherche

    2011 - 2011 Dosage d'entérotoxines afin de créer un kit de détection multiplexe de toxines staphylococciques.

  • ISIS - Stagaire en laboratoire de recherche à l'ISIS

    NEYRON 2009 - 2009 Recherche à l'interface microbiologie, biologie cellulaire, biochimie et physique dans le but de la production de protéines d'intérêt en quantité industrielle.

Formations

Réseau

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