Senior Consultant IVD
Senior Consultant
Introduction:
Since 2021 Aygül has joined the Qserve Group as senior consultant where she works as a clinical project manager for CRO. Aygül holds a PhD degree in Molecular Biology, Master’s degree in Molecular Bioengineering and Bachelor degree in Molecular Biology and Genetics.
Aygül about working at Qserve:
I’m passionate about helping manufacturers to provide a suitable clinical strategy that suits their profile. I have experience in working with clinical study management, coordination and scientific and clinical writing. I look forward to expand my knowledge and helping clients to ensure compliance on their medical devices and IVD’s.
Before Qserve:
Aygül has more than 10 years of scientific research experience (IVD research) and 7 years in Clinical Research in Medical devices.
Her areas of expertise in IVD are Cancer Research, Cell Biology and Stem Cells. In Medical devices, her experience focus is on all class devices in interventional cardiology, Radiology, ENT& Wound healing devices.
In the past Aygül held a management position in Clinical Affairs Department in an international medical device manufacturer company. In this role she was responsible for designing clinical strategy and program to ensure compliance with Directives and Regulations. Moreover, she was responsible for execution of the preclinical studies including biological safety testing, assessments and animal studies.
The key expertise area of Aygül:
- Clinical strategy & clinical study management (design, resource allocation, feasibility, execution & monitoring, safety reporting, interim & final reporting)
- CRO management and clinical study coordination
- Scientific writing and publication (author of high-impact journals)
- Clinical writing (CERs, CEPs, Study Protocols, IBs, CRFs, Final Reports, PEPs, PERs, LSPs, LSRs)
- Post market activities (PMS/PMCF/PSUR)
- Biocompatibility testing, assessment & animal studies in accordance with the applicable standards and local regulation requirements
- Knowledge of MDR 2017/745, IVDR 2017/746
- Knowledge of ISO 14155, ISO 10993, ISO 14971,ISO 20916, ICH-GCP, MEDDEV 2.7/1 rev. 4.
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Qserve CRO