Munich, Bavaria, Germany
Clinical research professional with 10+ years of experience in Germany and the UK across sponsor, CRO, and site environments. My background combines clinical project management, study execution, vendor oversight, contract review, medical writing, regulatory coordination, and team leadership across international phase I–III studies. I have worked in cardiology, haematology, immunology, neurology, oncology, pulmonology, and other therapeutic areas, with particular interest in rare and hereditary disease. My recent work has focused on sponsor-side clinical management in pharma/biotech, including CTIS/IRAS submissions, CRO and third-party vendor oversight, budget control, investigator meetings, SOP-related documentation, and cross-functional delivery through key study milestones. I bring a broad clinical research perspective shaped by experience in biotech, generics, CRO, and hospital-based research settings. Connect where phase I–III delivery, CTIS-era execution, and cross-functional clinical project or study leadership are the focus.
o Led phase I–II clinical studies with responsibility for timelines, budgets, and management reporting. o Directed CRO and third-party vendor selection, oversight, performance assurance, co-monitoring, and budget negotiation. o Reviewed site, CRO, and vendor contracts in collaboration with legal counsel. o Wrote and reviewed protocols, patient information sheets, informed consent forms, clinical study reports, SOPs, handling instructions, and process descriptions. o Supported regulatory submissions and authority / ethics committee communication in the EU and US, including IRAS and CTIS. o Acted as deputy to the Vice President Clinical Operations, led internal teams and stakeholders, and supported training, capacity planning, and change-related activities.
o Managed phase I–II clinical studies with oversight of timelines, budgets, and study status reporting. o Oversaw CRO and vendor selection and performance, including co-monitoring activities. o Reviewed site and vendor contracts and collaborated with legal counsel. o Contributed to protocols, informed consent forms, patient information sheets, clinical study reports, and related trial documentation. o Supported regulatory submissions and communication with competent authorities and ethics committees, including CTIS and IRAS processes.
o Developed and implemented the Clinical Study Centre concept and established new structures and systems. o Managed staff reporting lines, hiring activities, capacity planning, and trainee support. o Held responsibility for study contract negotiation, budget oversight, and budget planning. o Built external relationships with vendors, sponsors, and partners and negotiated master service agreements and collaborations. o Led vendor bidding and contract negotiation processes.
o Designed and managed international phase I and phase III clinical trials, including bioequivalence, specialty, and paediatric studies. o Performed monitoring activities for phase I clinical trials. o Functionally led internal teams and managed internal and external stakeholders. o Ran vendor-related activities including requests for proposals, vendor selection, and training support. o Managed contracts, budget tracking, financial reporting, and spending negotiations. o Contributed to protocols, patient-facing documents, clinical study reports, briefing books for scientific advice meetings, and Investigator Brochures.
I took a planned career break to travel extensively throughout England and immerse myself in its culture, history, and regional diversity. This experience enhanced my adaptability, broadened my perspective, and strengthened my intercultural communication skills.
o Compiled and submitted physical and digital clinical trial applications in the EU and Switzerland. o Communicated with competent authorities and ethics committees regarding submissions and approvals.
o Covered clinical project management, clinical trial monitoring, team leadership, budget responsibility, and medical writing. o Achievement stated in the CV: set up an investigational site from scratch with no significant findings in subsequent audits and inspections.