Skill set
Top skills
Additional skills (2)
Industry fields of expertise
Karim in a few words
Clinical Research Consultant with more than 17 years of experience as a CRA/LCRA/Country Study Manager/CTM tasks in different countries such as France, United Kingdom, Europe.
Supervising, managing studies and teams of field CRAs (up to 25) all over Europe, USA, South America.
Worked on Clinical trials in different Therapeutic areas: Hematology/Oncology, Cardiology/Vascular Diseases, Endocrinology/Metabolic Diseases (Medical Devices), Digestive, Genitourinary, Respiratory, Infectious/Parasitic Diseases, and Central Nervous System, Ophthalmology.
Gained significant experience in Hematology/Oncology, Rare/Orphan disease, as Senior CRA/Lead CRA with CTM tasks/Country Study Manager.
Experience in Clinical trials phases I-IV in both adult and pediatric populations,
Performed all types of Monitoring Visits in the UK/Ireland, EU: Sites set-up, PSV, SIV, IMV/Co-monitoring and COV, quality assurance visits. Vendor management, Budget and contract negotiations, review of submission packages to the regulatories agency and ethics committee (local, central).
Used different Clinical and/or client specific systems for trial management, such as EDC, CTMS, IVRS, IWRS, eDiaries, Spotfire, powerBI, vTMF, Veeva CTMS.
Performed 100% or reduced SDV, Monitoring on-site and remote visits.
Strong experience in submissions to HRA/NREC/MHRA/R&D/NIHR and also in France, Belgium, Germany, Ireland, Spain, Italy, Austria, Switzerland, Poland, Norway, Finland, Ireland, Hungary
Familiar with AIM methodology and trained in Risk Based Monitoring, Centralised Based Monitoring.
Expertise with MHRA preparations, European agencies inspection, sponsor and internal audits, site and TMF audits preparation, readiness, quality assurance
Experience
- Seagen Inc.MrBIOTECHDecember 2019 - Today (5 years)LCRA with CTM task managing late phase studies in oncology for the European region.
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