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Jessica PAPUGA, PHD

Paris

En résumé

Besides my PhD and postdoctoral background, I have gained valuable experience in clinical trial management while working at CRO (Quintiles) and sponsor (Sanofi) level. I have rapidly embraced new responsibilities and challenges. Indeed, I became Data Operation Coordinator and Operational Lead on the one hand and, CTOM and program DM lead on the other hand. Having a 'big picture overview' of projects and program led me to adapt and to strengthen my autonomy. In addition, I have taken benefit of my previous scientific background to respect the deliverables in a timelines as well as a quality expectation manner.
To summarize, my experience in the DM field allowed me to develop and improve competencies such as project management, communication and leadership. The combination of my previous scientific experience to my CRO and sponsor-related experiences drives a motivating upwards swinging movement. I currently work as Clinical Trial Operation Manager (Program DM Lead) at Excelya on behalf of Sanofi.

Mes compétences :
Microscopie
Biologie cellulaire
ICH/GCP
Data management
Oncologie
Biologie moléculaire
Leadership
Autonomie
Flexibilité
Communication
CRO oversight
Diabète

Entreprises

  • Sanofi - Clinical Scientist

    Paris 2017 - maintenant Excelya on behalf of Sanofi
    Phase III clinical trials - multicentered, worldwide

    *Protocol deviations: definition, detection and follow-up of corretive actions
    *Development and implementation of informed consent & written subject information and personal data protection compliance
    *Ensuring medical quality and patient safety (medical data review and validation)
    *Contribution to key study documents (i.e. extended synopsis, adjudication committee contract, financial disclosure and charter, protocol amendment, patient profiles, data surveillance)
    *Working within trials that are part of the Common Protocol Template Initiative (Transcellerate)

    Therapeutic area: Diabetes

  • Sanofi - Clinical Trial Operations Manager / Study Manager

    Paris 2016 - 2017 Excelya on behalf of Sanofi
    Program DM lead - Phase III clinical trials, multicentered, worldwide
    * Scope of work: identification of sponsor DM requirements, alignment with all parts of full package outsourcing, cost estimation review
    * Sponsor DM representative - CRO oversight - study start-up
    * Harmonization of processes at program level
    * Collaboration with Transversal Operation Expert for full package outsourcing implementation

    Therapeutic area: Diabetes
    Instance: Rave Medidata

  • Sanofi - Clinical Trial Operations Manager / Study Manager

    Paris 2015 - 2016 Excelya on behalf of Sanofi
    Phase III clinical trial - multicentered, worldwide
    * Management of in-house and outsourced data management (DM) activities:
    DM key contact for clinical study director, biostatisticians, regional trial managers, global pharmacovigilace, medical writters
    Oversight of CRO conducted DM activities
    Pre-Approval Inspection readiness
    CRA training - Newsletter - Reporting
    Onboarding of new CTOMs
    Study conduct and close-out
    * Management of immunogenicity samples related activities: sample selection and shipment, interaction with analytical laboratory through sample manager, data receipt after database lock
    * Adjudication committee related activities: adjudication form design, patient selection, package preparation, adjudication decision collection, interaction with data entry team

    Therapeutic area: Diabetes
    Instance: OC-RDC

  • Quintiles Strasbourg (CRO) - Clinical Data Manager

    2013 - 2014 * Operational Lead - Phase I clinical trial: eCRF design, database set-up, data
    review, validation processes, out-of-site collaborator management, data
    management plan set-up, study-specific financial tool
    * Data Operation Coordinator - Phase II clinical trial: data review, third part
    vendor management, coding (WhoDrug, MedDRA), study close-out
    Therapeutic area : Oncology
    Instances: Inform 4.6; Inform 5.5

  • GIGA-R/ University of Liège (Belgium) - Post-doctoral researcher

    2011 - 2013 * Breast cancer project management, publication writing, funding application,
    oral and written communications
    Research area: Oncology

  • CRP-Santé Luxembourg - Post-doctoral researcher

    2011 - 2011 * Experiment set-up
    Research area: Cell biology

  • CRP-Santé Luxembourg - PhD Student

    2007 - 2011 * Thesis project management, experiment set-up, funding applications,
    publication writing, oral and written communications
    Research area: Cell biology

Formations

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