Regulatory Affairs and Start-up Specialist

11/2023 – 9/2024

-Perform submission (IRB, EC, CA) and other Regulatory Bodies on behalf of sponsors.
- Compile Regulatory documentation according to the SOP's and applicable country requirements, perform QC checks.
- Adapt Informed Consent Form (ICF) according to the IRB/EC requests on country or site level. (DE, ES and FR)

Gute Klinische Praxis, Softwaredokumentation

3/2022 – 10/2023

- Site contracting study start-up phase, focus oncology studies.
- Develop process documentation.
- Developing study specific contracting and budgeting strategy with the internal stakeholders
- Primary contact and process owner for interactions between TC and Lilly US, Legal / Finance related to process changes, documentation requirements, and site contracting and budgeting issues.
- Development and realization of terms and provisions for country specific templates (implementation of EU 536/2014).
- Supporting, adapting and submission of relevant study documentation for CTIS submission (Part I and Part II) for DE and AT.
- Adaptation and revision of ICFs, SOPs and eTMF specifications to EU No. 536/2014.
- Contracting in compliance with planned enrolment timelines (90%).
- Mentoring and training of new hires.

Projektdurchführung

7/2021 – 2/2022

-Managing of the feasibility process, recruitment support and strategies, study project management,
- Set-up of study budgets, negotiations - and contracting,
- Line - management function,
This role was limited as a parental leave replacement

Gute Klinische Praxis