Babette von Hagen

Leading a team of Global Project Lead Data Managers in Marburg/Germany in a global enviroment. Passion for a collaborative and people-first culture. Focus on the Therapeutic Areas Immunology and Respiratory. Continuously optimizing processes in the changing Data Management environment, e.g. Decentralized Trials.

Leadership of the overall data management process supporting projects/programs for clinical studies within the scope of project timelines. Oversee project specific database design and eCRF builds according to CSL's Clinical Standards. Oversee the testing of data management system edit/validation checks and special listings/procedures used as tools for data review and discrepancy management activities.

Implementation of the international global clinical trial process via appropriate project and budget planning and project oversight. Responsible for managing study execution and providing oversight to investigational sites. Developing and maintaining study timelines, forecasts and tracking study Budget. . Communication and effective working relationships with internal departments and external study vendors: CRO, Data Management, Central Laboratory.

Support of the execution of global clinical studies and providing oversight to investigational sites Developing and maintaining study timelines, forecasts and tracking study budget Ensuring excellent communication and effective working relationships with external study vendors Supporting the on-time delivery of the clinical trial

Contribution to the execution of global clinical studies and all study related tasks in compliance with SOPs, ICH-GCP and regulatory requirements Coordination of clinical study team and external vendors Assistance to implement the clinical trial process

Member of the research team Neuroimmunology and organization of the related outpatient department Coordination of Phase II to IV studies and Investigator Initiated Trials in the departure of Neuroimmunology in MS, CIDP, Myasthenia Gravis and Alzheimer disease Organization of on-site patient visits including sample shipment, drug accountability, eCRF entries

Nursing and clinical care of patients with neurological diseases such as Multiple Sclerosis, Parkinson disease, stroke, Alzheimer disease, Epilepsy Graduated “Study Assistant for Clinical Trials”, Goethe University, Frankfurt, Germany.