Martin Rep
SERVICES
Martin Rep
Site Identification and Feasibility
Overseeing site identification for oncology, neurology, cardiovascular, hematology, infectious disease, mental disease, musculoskeletal disease and dermatology studies in phases II-IV. Feasibility. Managing teams of site contact associates in EU, USA and APAC for the collection and collation of internal and external information and evidence to support site identification. Ensure standard processes, tools and procedures are used consistently for study execution. Building relationships with researchers / sites and networks in European countries for conducting feasibility studies.
Clinical Data Management
Data management of, in particular, phase III clinical drug trials. Building databases, data management, quality control of CRFs and protocols. Create validation plans. Create and edit working procedures for data management.
Clinical Monitoring
Conducting qualification visits, initiation visits, interim monitoring visits and close-out visits in the Netherlands and in Belgium. Site management.
Project and Clinical Team Management
Project management responsibility for clinical drug studies in EU for phase II-III studies. Managing and training of clinical operations teams. Support of regulatory submissions. Reporting study progress and final results to clients. Line management. 1:1 coaching and coaching of inexperienced / less experienced colleagues.
Study Start-up
Site selection, site start-up (including EC / CA submissions and contract negotiations with the research centers)
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QUICK LINKS
SERVICES
Site Identification and Feasibility
Clinical Data
Clinical Monitoring
Project and Clinical Team Management
Study Start-up
Clinical Data
Clinical Monitoring
Project and Clinical Team Management
Study Start-up