Germany
As a Global Clinical Project Leader at Parexel with over nine years of experience in this role, I focus on early-phase oncology and neurology product development. My expertise includes protocol review, risk management planning, budget development and management as well as milestone tracking for complex clinical studies. I lead cross-functional teams and collaborate closely with internal and external stakeholders to ensure high-quality execution while addressing challenges through proactive risk management. With a certification as a Project Manager for Clinical Trials and an advance degree in biology, I am responsible for end to end study execution from kick off till Clinical Study report publication.
Embedded within a Boehringer Ingelheim [Innovation Unit] under a FSP model employed by Syneos Health - Accountable for operational performance of the study and study oversight - Medical / scientific accountability - Strategic input for early clinical development - Leads Trial Oversight Meetings (TOMs) - Shared monitoring oversight tasks
Global Clinical Project Leader, with Focus on early product development in Oncology, Protocol review, Risk management Plan creation, Leading cross-functional team meetings, Client meetings, Budget forecasting and review, Milestone management (recruitment, DBL), Track and control of expenditure, Issue and quality Management (CAPA-Lead), Newsletter development, Study plan modification
Focus on Phase I and IIa, Global Clinical Project Leader, Protocol review, Risk management Plan creation, Start up lead, Monitoring report review, Monitoring plan development, Leading cross-functional team meetings, Client meetings, Protocol training for CRA-teams, Training and quality Co-visits, Budget forecasting and review, Milestone management (recruitment, DBL), Track and control of expenditure, Issue and quality Management (CAPA-Lead), Freelance CRA contract negotiation, Newsletter development, Study plan modification, external data management/Laboratory/Video-EEG & ECG-Vendor management, Transfer of sponsorship from sponsor to sponsor, Bid defence meeting;
Country Study Manager Germany Fully outsourced to leading pharmaceutical company Oncology Business Unit Coordination and management of over ~300 sites and ~1500 patients Ensure delivery of milestones and project goals Budget responsibility on national level Regulatory and ethic submission CRA team management
Clinical Monitoring and Site Management, Site identification, Ethic Committee-submission, contract negotiation, all visit types (Site selection, Initiation, Monitoring, close out) Indications: Diabetes Mellitus type II, Prostate Cancer, NSCLC
molecular biologic and microbiologic research projects in the field of transcription/antisense RNA Broad education in oncology, detection and treatment for all types of cancer (in example: melanoma; prostate, brain and lung carcinoma; mamma carcinoma; leukaemia and virus induced carcinomas) at the German Cancer Research Centre, Heidelberg in the “Progress in Cancer Research” Lecture series