Experience

DeSia Clinical Research

• Türkiye
• Research Services
• 1 - 100 Employee

• Clinical Affairs Team Leader

  • Aug 2021 - Present

  • Supporting and guiding the clinical team • Responsible for implementing clinical strategies • Responsible for project management • Managing the integrity and accuracy of clinical and regulatory data• Performing gap analysis on a clinical strategy to establish clinical evidence • Assessment and verification of clinical evidence requirements and clinical documentation to comply with medical device regulations/standards/guidelines

• Junior Clinical Evaluation Specialist

  • Sep 2019 - Aug 2021

  • Responsible for the preparation and maintenance of clinical documents related to EU regulatory compliance for medical devices, including Clinical Evaluation Plans/Reports, Post-Market Clinical Follow-Up Plans/Reports and other clinical documents as needed (e.g., investigator brochures)• Conducting gap analysis on Clinical Evaluation Plans/Reports • Developing and implementing Clinical Investigation Plans/Reports • Ensuring compliance with regulatory and clinical standards and guidelines • Conducting literature search for clinical data relevant to the device under evaluation or equivalent/similar device, and searching for current knowledge/the state of the art• Summarising post-marketing surveillance and risk management data for the target device• Managing the integrity and accuracy of scientific, medical and regulatory information• Studying and reporting device characteristics and instructions for use Show less