Clinical Expert

With over 20 years of experience in clinical research, she excels in managing phases II, III, and IV studies, including non-interventional and ENCEPP projects, across various therapeutic areas such as oncology, neurology and cardiovascular

She has a proven track record in clinical project management, overseeing post-drug approval research and managing global and local clinical trials, particularly in oncological therapy areas, ensuring effective interface management and training

Her expertise includes regulatory submissions and clinical approval processes in the DACH region, with a focus on generating post-approval data and medical evidence in neurology, particularly in multiple sclerosis

Was placed as a Clinical Trial Manager via K-Recruiting with best references

Project management and coordination of clinical trials

Selection of external service providers and trial centers

Coordination and support of participating trial centers, i.e., assisting trial centers with content-related, methodological, and organizational issues

Liaison/communication interface between sponsor, project management, monitoring, statistics, and trial centers

Obtaining the necessary approvals from ethics committees and authorities

Organization of the provision of trial medication (in cooperation with the respective pharmaceutical company)

Close cooperation with the study management and the committees

Conduct and oversight of the execution of post-drug approval research

PASS DUS study management

Project management of global and local clinical trials with a focus on oncological therapy areas

Interface management with internal and external parties

Ensuring and organizing training of investigators and clinical study team in study related procedures

Regulatory Submissions to Authorities, Ethics - DACH Region

Support the generation of post-approval data and medical evidence in Neurology - Multiple Sclerosis – a real-world evidence program

Working across late-stage development and marketed products

Manage the operations for Phase 4 studies, patient registries, outcomes research

Driving data generation program execution

Study planning, start-up, vendor management, site management, tracking and reporting

Review committee coordination, contracting, study management team formation, publication support, filing, milestones and budget

Provide regular updates to internal clinical trial management system for departmental projects, and compile reports from the system

Study Management with tracking and update of the medical dashboard

Act as a key point of contact between Medical Research Operations group and the external research stakeholders and partners

International Phase III Study – Glioblastoma

Investigator Initiated Trial (IIT) Leukemia, Myodysplastic Syndrome (MDS)