Carole ABÉGUILÉ

En résumé

Entreprises

• Clearstone Central Laboratories (anc. MDS Pharma Services)

  maintenant

• MedPass International - Clinical Project Manager

  2011 - maintenant - Management of international clinical trials as main contact for medical device manufacturers.
  - several fields of activity: interventional cardiology, peripheral vascular disease, neuromuscular stimulation.
  - Set-up of the studies including site selection, initiation and monitoring, safety reporting organization and patient data collection.
  - Activities in collaboration with cross-functional teams: clinical (coordination of several CRA teams), regulatory affairs (submission to Ethics Committees and Competent Authorities), biometry (EDC, CRF data entry), business development (budget/invoices follow-up)

• Synarc - Senior Project Manager

  2007 - 2011 - Management of phase II to IV international clinical trials and programs:
  Central Nervous System - Neurovascular (stroke)
  Cardiovascular (diabetes and dyslipidemia)
  Cardiology - Cardiac Safety
  Oncology - RECIST criteria (breast cancer)
  Dermatology
  - Responsible for fulfilling client requirements in terms of deliverables and timelines in respect with clinical regulations.
  - Budget and finance driving for each project.
  - Management and negotiation with the clients of “out of scopes” and change orders of each contract.
  - Development of study documents in cooperation with medical/scientific team.
  - Communication and training of persons involved in the projects
  - Organization of investigators/experts meetings.
  - Cross-functional activities with clinical operation, data management and commercial (RFP / Bid-defenses) teams.
  - Supervision of a junior project manager.
  - Preparation and participation at audits (internal and client).

• MDS Pharma Services - Centralized Cardiac Services - Senior Project Manager

  2005 - 2007 - Management of a team of 9 persons (Project Leaders and Coordinators): performance appraisal and personal development.
  - Management of activity metrics (volume and resources): allocation of resources on new projects.
  - Work in collaboration with cross-functional peers to manage workflow depending on client requirements and constraints.
  - Development of logistics processes for ECG recorder supplies and set-up of an inventory on Access.
  - Involvement in RFP/RFI and Bid-defense by bringing technical expertise during protocol and quotation review.
  - Revision and development of procedures and participation at audits.
  - Preparation of patients files of 2 studies and successful participation at an FDA inspection.
  - Optimization of operational process with teams based in Toronto and Singapore.

• MDS Pharma Services - Centralized Cardiac Services - Project Leader

  2003 - 2005 - Management of phase I to IV international clinical trials and programs.
  - Main contact of the pharmaceutical client laboratories (cardiology, psychiatry, endocrinology, immunology, virology).
  - Work in cooperation with other cross-functional teams.
  - Responsible for fulfilling contractual requirements and following-up their consistency with client expectations insuring compliance with current procedures and regulatory practices.
  - Training of persons involved and presentation at investigators meeting.

• MDS Pharma Services - International Project Coordinator

  2002 - 2003 - Logistics coordination and monitoring of biological analysis centralization for international clinical trials.
  - main contact of investigators and CRAs

Formations

• Université Compiègne (Compiegne)

  Compiegne maintenant

• Technische Universität Dresden (Dresden)

  Dresden 2001 - 2001 Study semester (biological engineering)

• Université Compiègne Université de Technologie de Compiègne (UTC)

  Compiegne 1996 - 2002 Biological Engineering (biotechnology : Design and Innovation of Bio-products)