Experience
Overview
An accomplished Project Manager, Sr. Clinical Research Associate & Clinical Research Auditor with 20 years of extensive clinical research experience, a certified Clinical Research QA Auditor, providing timely project solutions and services to leading Pharmaceutical, Medical Device and Biotechnology according to ICH-GCP as well as local and international regulations.
Therapeutic Experience
| ♦ Oncology | ♦ Cardiovascular |
| ♦ Critical Care | ♦ Hematology |
| ♦ Infectious Diseases | ♦ Women’s Health |
| ♦ Neurology | ♦ Medical Device |
| ♦ Renal | ♦ Ophthalmology |
| ♦ Dermatology | ♦ Pediatric |
| ♦ Gastroenterology | ♦ Rare Diseases |
| ♦ SCD (OTA) | ♦ Late phase/Registry |
| ♦ Orthopedic: Surgery/chondrocytes graft treatment and Tissue Engineering | |
Relevant Professional Experience
Project Manager
Regional Senior Clinical Research Associate
CQA Auditor
Manage and co-ordinate cross functional tasks, sites selection, pre-study and start-up activities; manage study issues, assure the implementation of project plans as assigned, Ethics committee and competent authority regulatory affairs and submissions of clinical trials applications, Core monitoring tasks and tracking of clinical trials assignments, local regulations, study requirements and protocol, CRF and SOP development & design
Collaborating with other functional groups to co-ordinate and manage study issues.
Client interactions –liaising with sponsor development updates and meetings.
Perform all study related visits; preparation of scientific documents (i.e. clinical reports); provision of technical guidance and logistic services; data management; training and guidance of investigational staff
Conducting Late Phase/Registry – Observational and Retrospective studies
Implementation of Electronic Data Capture systems (EDC) – development, training and support
