Nur Beril Deniz
Istanbul,34
Summary
I am constantly striving to increase the number of successful projects completed and to further specialize in data analysis using imagination and analytical skills. With effective communication and teamwork skills, I aim to ensure the smooth running of clinical research.
Overview
4
4
years of professional experience
Work History
Clinical Trial Assistant
Mene Health Group
04.2022 - 12.2023
- Worked with multiple sponsors on medical devices, early access to medicines, and phase I-III and IV drug trials.
- Management and submission to MOH of all import license(IL) applications.
- Prepares and submits initial and ongoing submissions, amendments, safety, and other study notifications required by EC and MOH.
- Ensure all relevant documents are submitted to the electronic Trial Master File (Vevault system etc. ) as per Sponsor SOPs
- Local Investigator Contract and Budget Negation- Supports Project Manager to agree on our country's clinical trial agreement(CTA) and budget.
Clinical Research Site Coordinator
Mene Health Group
03.2020 - 04.2022
- Coordinated site investigations, documented issues, and escalated to executive teams.
- Scheduled staff and volunteers to cover all necessary duties during planned events.
- Worked with sponsors including Abbvie, Jansenn, Astrazeneca and Bayer in areas of gastrointestinal, dermatology, cardiovascular and infectious diseases.
Clinical Research Site Coordinator
Atlas CRO
07.2019 - 03.2020
- Coordinated site investigations, documented issues, and escalated to executive teams.
- Scheduled site staff and volunteers to cover all necessary duties during planned events.
- Worked with multiple sponsors in areas of gastrointestinal, dermatology, haematology and oncology.
Education
Bachelor of Science - Bioengineering
Yıldız Technical University
Istanbul06.2019
Skills
- Regulatory submission
- Trial Master Files(TMFs)
- Veeva Vault
- Teamwork
- Import License submission
- Site Start-up
- Medical Device
- Early Access of Drug trial
Languages
Turkish
Native language
English
Upper intermediate
B2
Timeline
Clinical Trial Assistant
Mene Health Group
04.2022 - 12.2023
Clinical Research Site Coordinator
Mene Health Group
03.2020 - 04.2022
Clinical Research Site Coordinator
Atlas CRO
07.2019 - 03.2020
Bachelor of Science - Bioengineering
Yıldız Technical University