Performance-driven and dynamic professional with substantial experience in managing all facets of clinical operations.
Aktualisiert am 12.02.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.03.2024
Verfügbar zu: 75%
davon vor Ort: 0%
Clinical Trials Operation
Reporting and Documentation
Cross-functional Collaboration
agiles Projektmanagement
Good Clinical Practice
Clinical Monitoring
Research and Analytics
Regulatory Compliance
Team Training and Leadership

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

3 months
2023-11 - now

Reviving a study site as Clinical Research Coordinator

Clinical Research Coordinator agiles Projektmanagement Good Clinical Practice
Clinical Research Coordinator
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.
agiles Projektmanagement Good Clinical Practice
WCG Clinical Services
Bad Bramstedt
2 years 5 months
2021-09 - 2024-01

Support Clinical Data Management

Clinical Data Manager
Clinical Data Manager
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:
? Ensured high data quality through data monitoring, guaranteeing site and data compliance with ICH-GCP, regulatory requirements, and trial procedures.
? Optimised collaboration and efficiency whilst spearheading cross-functional clinical research services as Freelancer.
? Met and surpassed set expectations by offering high quality products and services.
? Consistently delivered effective solutions to complex challenges.
Merck Group
Remote

Aus- und Weiterbildung

10 years 7 months
2013-08 - 2024-02

Epidemiology

Master of Science, University Medical Center of the Johannes Gutenberg University
Master of Science
University Medical Center of the Johannes Gutenberg University
Clinical Research and Biostatistics
8 months
2017-10 - 2018-05

Clinical Monitoring

Certificate, Pharmaakademie GmbH
Certificate
Pharmaakademie GmbH
Clinical Monitoring, Good Clinical Practice, Clinical Trial Management

Position

Currently interested in roles as:

  • Clinical Trial Manager
  • Senior Clinical Trial Associate
  • Central Monitoring
  • Remote Monitoring

Kompetenzen

Top-Skills

Clinical Trials Operation Reporting and Documentation Cross-functional Collaboration agiles Projektmanagement Good Clinical Practice Clinical Monitoring Research and Analytics Regulatory Compliance Team Training and Leadership

Klinische Forschung

Clinical Operations
Fortgeschritten
Clinical Data Management
Fortgeschritten

Branchen

Pharmaceutical Industry

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