Carole Abéguilé

- 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).

- 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.

- 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.

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