Clinical Project & Site Management

CLIPS - Clinical Project Services ®: conduct of, and independent consulting for all or any operational aspects of a clinical trial

Project Management (Study setup, applications, conduct); Site Management (Monitoring/Supervision); Scientific Writing

• Business Development
• Compliance management
• Management (allg.)
• Medizinforschung
• Projektmanagement
• Risikomanagement
• Schulung / Coaching (allg.)
• Sprache (allg.)
• Übersetzungen
• Unternehmensberatung

I am offering national/international project management for your clinical trial. Much experience in study start-up activities (Clinical Trial application to EC and CA!). For monitoring tasks, regional assignement is preferred.
Experience in Phase II, III, and IV studies; main indications: oncology, dermatology, vaccine, rheumatology. Details & full project list, together with CV will be made available upon request.

Memberships
•GQMA (formerly DDG; active involvement in the GCP-work group)
•CRA-net

•Site Management: site selection and all or any aspects of site management during ongoing study: in-house monitoring, monitoring visits & reporting, remote support for sites
•Study Management: manage activities related to an assigned clinical trial on behalf
of the sponsor (pharmaceutical company or investigator) or CRO, including feasibility, set-up (e.g. CTAs to EC and CA), conduct and wrap-up, as well as TMF-maintenance
•Team Management: coordinate internal project team and consulting groups (if appl.), communicate with sponsor project management, ensure roles and responsibilities, as well as goals and targets are clear across internal and external organizations;
experience in working with functional groups i.e. DM/Biostatistics, Medical writing, Medical monitoring/Safety, Regulatory Affairs, etc.
•Budget & Risk Management: oversight over timelines, budget, team performance
- manage project metrics and, if necessary, develop CAPA and mitigation
•Information Management: trainings on ICH-GCP / AMG / GCP-V, on any and all operational aspects of a clinical trial, on selected scientific topics (e.g. laws & regulations, human physiology, psychopathology, systemic counselling)
•Documents Management / Scientific Writing: preparation / review of ICF, Protocol, Clinical Study Report (CSR), Manuals & additional instructions; independant quality check of Trial Master File (TMF); scientific publications, presentations and literature research

•all Office Applications (up to and including version 365)
•various eCRFs and Clinical Trial Management Systems

•regular certified trainings in ICH-GCP; AMG, GCP-V, MPDG; MDR, CTR, IVDR