Vinciane DUMAY

En résumé

Entreprises

• PPD - Home-based Senior Clinical Research Associate 1

  2016 - maintenant Dedicated to GSK Pharma

• PRA Health Sciences - Home-Based Clinical Research Associate II

  2015 - 2016 Phase III in Relapsing-Remitting Multiple Sclerosis or Clinically Isolated Syndrome (Neurology):
  - Start-up tasks as IHCRA role: EDs collection (CDA, CVs, ICH-GCP), feasibility (SRQ).
  - CRA role with 6 on-site PSSVs and 1 phone PSSV.
  9 sites to be selected in France, 2090 patients to be included.
  
  Phase III in Hairy Cell Leukemia (rare disease, Hematology): Recruitment period is ongoing, 77 patients, 67 sites worldwide.
  - Investigator meeting at Marseille
  - 10 SIVs (2 SIVs as visit leader)/12 French sites
  - 2 IMVs (the first patient included in France)
  Phase III in metastatic and/or unresectable gastrointestinal stromal tumors (solid tumor, oncology): maintenance and close-out phases.
  - 14 IMVs at 3 sites, 4 patients
  - 2 COVs
  
  Phase II in advances transitional cell Carcinoma (solid tumor, oncology): re-monitoring assignment following sponsor audit, 3 sites, 11patients.
  - 9 re-IMVs with management of external CRAs data to be included in IMV reports written
  
  Phase III in Rheumatoid Arthritis (Autoimmune disorders, Immunology): feasibility phase. 300 patients, 80 sites. 5 sites to be selected in France
  - 5 on-site PSSVs
  2 studies to be presented, Phase III in Hepatitis B Virus (infectious disease): feasibility phase.
  - 1 on-site PSSV and 1 phone PSSV
  
  Phase II in Idiopathic Pulmonary Fibrosis (pneumology): start-up, recruitement and maintenance phases. 500 patients, 180 sites. 9 sites to manage, 42 patients screened, 17 randomised
  - 2 investigator meetings (initial and protocol amendment)
  - 9 SIVs
  - 49 IMVs
  - 1 sponsor audit: no major or critical finding.
  - 1 COV
  
  Phase III in Mild Ulcerative Colitis (Autoimmune disorders, Immunology). Maintenance and close-out phases. 400 patients. In France: 9 sites, 13 patients.
  - 13 IMVs
  - 9 COVs

• PRA International - Home-based Clinical Research Associate I

  2014 - 2015 General Responsibilities:
  
  • PSSVs, SIVs, IMVs, re-IMVs, COVs, booster visits, investigator meetings and audit visits in accordance with sponsor and CRO SOPs, ICH-GCP requirements.
  • eTMF, CTMS, ISF maintenance
  • Site training on studies and ICH-GCP requirements, AE/SAEs reporting verification
  • Source Data Verification, queries resolution and site assistance (frequent communication), IP accountability, dispensation and compliance assessment, issues escalation
  • Visit leader, mentoring

• PRA International - Clinical Research Associate I

  2013 - 2014 OFFICE AUTOMATION SKILLS
  
  Office software: Excel, Word, Powerpoint
  Internet knowledge
  e-CRF: DataLabs, Medidata RAVE, intermediate level on CleanWeb designer
  IXRS: DataLabs, ClinPhone, MyTrial Perceptive, Bracket
  e-TMF and CTMS management knowledge
  Vendors: BMS, Perceptive, DataLabs, Fisher, Covance, LabCorp, eRT, Bioclinica.
  ICH-GCP guidelines knowledge

• Senior Clinical Research Associate (AP-HP) - Attachée de Recherche Clinique Sénior

  2012 - 2013 -Ophthalmology Study coordinator (20%) at Lariboisière (2 studies): patients follow-up (59 eligibilities), appointments management (6-7/patient), paper CRFs filling, investigator assistant for SAE and SUSAR declaration and follow-up (hospital report recovery) and patients information on the study.
  
  Senior sponsor CRA (80%): Cardiology (4 studies), Dermatology (1 multicentric study), Intensive care (1 monocentric study), Physical Medicine and Rehab (1 multicentric study), Neuro-Oncology (1 multicentric study). Protocols writing in collaboration with coordinator PIs, ICF ; assistant for IP supply chain design, prescriptions, patient card. CRFs design, constitution of submission dossier for competent authorities (CEC, ANSM), slides preparation for study setting up or kick off, constitution of TMF, ISF, reporting, eligibilities follow-up. Various kinds of studies: clinical trial on drug, not health product and medical device non interventional studies. IMVs in France, COVs (cardiology, SAMU, pharmacy on 6 sites), travel arrangements (travels, hostels). Studies with paper and electronic CRFs, queries follow-up, investigators meeting participation, newsletters design, investigators fees, reports writing, SAE or SUSAR follow-up.
  
  e-CRF Designer : Design of 3 e-CRFs (General Practice, Intensive Care, Neuro-Oncology), using CleanWeb software, with data control to relieve Data-Management work.
  

• Clinact - Central Instructor

  2011 - 2011 Epidemiologic study on supportive cancer therapy (data flowchart design and update, reporting participation, database management, investigator’s selection, phone initiations, contract management, patient’s enrolment and queries follow-up)
  
  Clinical trial on a medical device (TMF and ISF design, monitoring guidelines writing, sponsor reporting writing, enrolment fax management)

Formations

• Clinact Formation

  Sevres 2011 - 2011 Clinical Research Associa

• Université Val D'Essonne Evry (UEVE)

  Corbeil Essonnes 2010 - 2011 Tissular, Cellular and Genetic Biotherapies Master's degree
  
  Grade AB

• Université Paris 7 Denis Diderot

  Paris 2009 - 2010 Microbiology Master's degree
  
  Grade AB

• Université Paris 7 Denis Diderot 3ème année

  Paris 2006 - 2009 Biochemistry and Molecular Biology Bachelor's degree
  
  Grade AB

Réseau

• Bertille Catine TCHANKOU LEUDEU

• Catherine ABDEL SAYED GERGES

• Jaouad BENHIDA

• Laetitia PACALET

• Myna YEBOAH

• Sabra HADAJI

• Svet KRISTOF MSC CCRA

• Tessier CAMÉLIA

• Thien Kim TRAN THI