Clinical Trial Professional
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- 21029 Hamburg
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- de | en
- 01.02.2024
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
11/2023 – offen
TätigkeitsbeschreibungIn 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.
Eingesetzte QualifikationenGood clinical practice (GCP), Good documentation practice (GDP, GDocP), Innere Medizin
9/2021 – 1/2024
Tätigkeitsbeschreibung
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
Tätigkeitsbeschreibung
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
5/2018 – 8/2019
Tätigkeitsbeschreibung
Performed independent Clinical Monitoring of Phase II/III trials in oncology and immunology as well as documented all site management activities from site selection to closure in monitoring visit reports. Determined improvement areas and addressed site issues by implementing corrective and preventive actions (CAPAs) in collaboration with project teams. Provided comprehensive training to site teams, covering all aspects of studies, ICH-GCP, and regulatory requirements.
1. Received internal operational excellence award for outstanding performance in managing five trial sites, representing 15% of all sites in awarded clinical trial.
2. Maintained 100% compliance in submission of trip reports and follow-up letters, ensuring transparent reporting.
3. Accomplished 100% success in meeting given timelines, demonstrating efficient project management skills.
Good clinical practice (GCP), Good documentation practice (GDP, GDocP), Onkologie
Zertifikate
Pharmaakademie GmbH
Ausbildung
University Medical Center of the Johannes Gutenberg University
Mainz
Hamburg University of Applied Sciences
Hamburg
Über mich
With 6 years clinical trial experience in different roles at Sponsor's, CROs, and sites, I know what it takes to balance competing tasks, adapt to shifting priorities, and proactively address emergent issues. Additionally, my talents in communication and relationship building will enable me to seamlessly integrate with your team and provide exceptional service to your clients.
I would bring the following strengths to your team:
1. Played key role in ensuring high data quality through data monitoring, guaranteeing site and data compliance with ICH-GCP, regulatory requirements, and trial procedures.
2. Rendered expert-level support in achieving optimal site performance, recruitment and retention, study supplies, and inspection readiness by overseeing multiple sites across diverse protocols.
3. Bestowed with internal operational excellence award for outstanding performance in managing five trial sites, representing 15% of all sites in the awarded clinical trial.
Weitere Kenntnisse
Project Management
Process Improvement
Strategic Planning & Execution
Reporting & Documentation
Regulatory Compliance
Cross-functional Collaboration
Team Training & Leadership
Research & Analytics
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
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