Premier Research group
- Senior Clinical project manager
2008 - 2010Primary liaison between Premier-Research and client on studies
•Manage mutidisciplinary the project team (CRAs, CTA…)
•Responsible for the quality, composition and maintenance of the study files
•Maintains working knowledge of assigned Protocols, CRFs and any other study related documents
•Write clinical protocol, Investigator brochure, clinical report, patient informed consent…..
•Develops a Project Plan compliance with the plan
•Maintains and evaluates study progress.
•Tracks and adheres to project budget and milestones.
•Participate in the site selection, and training of investigators
•Oversees the regulatory documents collection and submission process
•Maintains liaison with the QA personel to ensure a trial is appropriately audited
•Coordinates the data cleanup between clinical operation, data Management, Biostatistics and medical affairs
•Involve in Case report Form design and review
•Clinical Investigator agreement setup
•Verify study compliance with GCP regulation, SOPs and study project Plan
•Train and mentor Clinical Managers and CRAs
Fisher Clinical Services
- Project Manager IVRS
2007 - 2008•Advises client on different possibilities to handle the trial in IVRS, Coordinates the set-up and validation activities of new IVRS study.
•Provides users training at investigator meetings. Initiation & participation in client meetings, teleconferences, where appropriate.
•Coordinates activities of Packaging and Distribution to guarantee full service.
•Budget tracking and reconciliation according to deliverables and Milestones.
•Verify study compliance with GMP regulation, SOPs and study project Plan
Forenap Pharma
- Project manager
2004 - 2007Main client contact for designated projects and develop successful working relationships with clients.
• Work in close collaboration with other department (Data Management, Safety Dept. Investigators etc…..)
• Collaborate with Business Development to ensure timely. Study budget management.
• International non-clinical Project Management, organisation and planning of project development (pre-clinical package).
• Selection of partners (CRO’s) performing the various sub-contracted studies. Coordinate the activities of sub-contractors.
• Drafting studies protocols, analyses results and review of studies reports (in pre-clinical and clinical studies).
• Write regulatory documents (investigators brochure, business development plan, IB, Study report).
• Good knowledge of ICH Guidelines (GLP and GCP)
Institut für umweltmedizinische Forschung, Duesseldorf-Germany
- Chercheur
2001 - 2004Air pollution effects on Cardiovascular System (Isolated organs, cell culture, telemetry studies, calcium imaging, PCR, WB....)
•Pharmacology and Toxicology in vivo studies
•Pharmacokinetics
•Write study Protocols and scientific publications
•Assistance to PhD student.
