Skills
Seit 2007 arbeite ich in der klinischen Forschung.
2012 habe ich mich selbstständig gemacht und arbeite als Projekt-CRA & Medical Projekt Manager in unterschiedlichen Indikationen.
Projekthistorie
since
Feb. 2014: Project CTM/Lead CRA and Senior Clinical Research Associate
Responsibilities:
As CTM- coordination and management international CRAs team, Study budget tracking, review of CRO study documents, quality of all study deliverables, project management global Studies Phases I-III, MV Report Reviews, CRAs Mentor, Track patient recruitment and progress to study timelines.
As Sr. CRA- monitors investigational sites to ensure subject safety and provide high quality data review and reporting in compliance with the project SOPs, GCP/ICH guidelines and other applicable regulations. Builds, manages and supports strong site relationships while serving as liaison between the Sponsor and assigned sites, Phases I-IV.
Karyopharm, Clinipace, IncResearch, CROMSOURCE
2012-2014: Medical Project Manager MSL Oncology
Responsibilities: Scientific, clinical and educational support to study sites and CROs (Full life cycle management from start-up and initiation, collection of study data & data quality, AEs/SAEs, eCRF training), recruitment-supporting measures, workshops, investigators & site staff training, advisor boards, Phases IIIb-IV. Novartis AG.
2007 - 2012 Trial Manager, leading Trial Project Team & responsible for the forecasting, planning, coordination, and execution of key supply chain activities in support of the global phase I – IV clinical program, clinical study protocols review, preparation regulatory documents for IMPD/IND filings, support generation of IVRS specifications and User Acceptance Tests, update and maintains cost estimate files. Boehringer Ingelheim Pharma GmbH & Co. KG
2007-2007 Project-CRA, Monitoring (periodical Monitoring Visits, Close-Out Visit) Oncology, AAI Pharma.
2006-2007 Regulatory Affairs Manager, Responsible for coordination & preparation of regulatory submissions, Update licensing and collect information on registration instructions and regulations, Dosiers update, Variations. AWD.pharma GmbH & Co. KG