Clinical Data Manager

11/2023 – offen

In this function, I am currently reviving a study site as sole study coordinator with the startup, initiation, and conduct of a Phase III trial in rheumatology after all study operations had been stopped for some time at the hospital. Namely, re-establishing processes, trial coordination, bringing necessary functions back onboard, patient recruitment and management, and trial documentation.

Good clinical practice (GCP), Good documentation practice (GDP, GDocP), Innere Medizin

9/2021 – 1/2024

In this role, I orchestrate end-to-end data management for Phase II/III trials from recruitment to database lock. Along with contributing to establishment and review of technical documents, including Protocols, eCRF completion guidelines, vendor management plans, and data management plans, I also foster problem-solving environment by identifying and mitigating risks within interdisciplinary teams.

Some of my key contributions includes:

1. Ensured high data quality through data monitoring, guaranteeing site and data compliance with ICH-GCP, regulatory requirements, and trial procedures.

2. Optimised collaboration and efficiency whilst spearheading cross-functional clinical research services as Freelancer.

3. Met and surpassed set expectations by offering high quality products and services.

4. Consistently delivered effective solutions to complex challenges.

Good clinical practice (GCP), Good documentation practice (GDP, GDocP), Neurologie

12/2019 – 2/2021

Conducted all monitoring visits from site selection to close-out by leading independent Clinical Monitoring of Phase II/III trials in oncology, immunology, and gastroenterology. Oversaw management of multiple sites across diverse protocols. Gathered, reviewed, and updated information for documenting progress reports. Streamlined operations without major quality findings whilst steering 15 trial sites across five global Phase II/III studies.

1. Achieved optimal site performance, recruitment and retention, study supplies, and inspection readiness by overseeing multiple sites across diverse protocols.

2. Attained 100% training compliance, demonstrating commitment to continuous professional development.

3. Gained 100% compliance in timely submission of trip reports and follow-up letters, ensuring transparent communication.

Good clinical practice (GCP), Good documentation practice (GDP, GDocP), Onkologie