Medidata(RAVE), Calyx(IRT), MonTe, Clario(eCOA, respiratory), PowerBI
Senem Sinem İncegil
Senior Clinical Research Associate
Istanbul,34
Overview
1
1
Language
13
13
years of professional experience
Work History
Senior Clinical Research Associate
AstraZeneca
09.2025 - Current
Clinical Research Associate
AstraZeneca Pharmaceuticals
05.2024 - 09.2025
- Supported quality oversight and compliance activities in clinical operations
- Contributed to CQAD support responsibilities for approximately 6 months
- Organized content for key trainings including RDC, SQRA, MonTe, SDA, and Delegation Log
- Supported monthly team meetings, workshops, and poll organization
- Contributed to local onboarding activities for new team members
- Assisted in the development of local work instructions such as SQV
- Improved knowledge sharing and operational efficiency through training and process guidance
- Collaborated with stakeholders for timely and site-specific document preparation
Clinical Research Associate
Fortrea Through AstraZeneca
09.2022 - 05.2024
- Led site management activities, ensuring compliance with regulatory standards and protocols.
- Developed and implemented monitoring plans to assess study progress and site performance.
- Collaborated with cross-functional teams to facilitate effective communication and resolve issues.
- Conducted site visits for evaluation of data integrity and adherence to study timelines.
- Trained junior staff on clinical trial processes, enhancing team efficiency and accuracy.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Clinical Research Associate
ICON DOCS
08.2019 - 10.2021
- Conduct feasibility, selection, monitoring and closure visit activities. Monitoring activities include but not limites to;
• Conduct confidentiality agreement preparation, facilitation execution and negotiation
• Conduct risk based off site and on site monitoring visits
• Make risk assessment for each site to prioritize activities
• Ensure trial is being conducted according to the protocol GCP and company SOPs by site staff
• Oversight of site staff trainings
• Ensure recruitment rate is on track and recruitment plan is followed up by site staff. Built recruitment strategies with the sites, if needed
• Ensure patient safety, rights and data integrity are maintained
• Oversight of site/trial quality - Superuser roles are Trail Product Handling and label translation and internal submission of clinical trial products.
- Assisting training and mentoring less expert CRA’s dependent on level of experience.
Technical Documentation and Patent Specialist
World Medicine
05.2019 - 06.2019
- Determine technical information and documents for the preparation of the licence application dossiers for the domestic and foreign markets in the format required by the country regulation; creating CTD Module 3(3.2.P.1, 3.2.P.2, 3.2.P.3, 3.2.P.4, 3.2.P.5, 3.2.P.6, 3.2.P.7, 3.2.P.8)
- Evaluate the impact of the process es according to the registiration dossiers and the related country, take action.
- Preparing relevant parts of application dossiers by providing necessary documents for GMP application dossier.
R&D Analytical Development Specialist
Deva Holding
06.2013 - 04.2019
- Executing and monitoring TR, EU and FDA projects (literature screening, API selection and analysis, product analyses, validation-verification studies, stress test studies, leachable&extractable studies, implementing pilot scale production, analyse and monitoring stability process, creating CTD module 3 (3.2.P.4, 3.2.P.5, 3.2.P.6, 3.2.P.7, 3.2.P.8), answering the questions from authorities.
- Executing change control, deviation and complaint assessment procedures.
- Answering deficiency questions coming from FDA and EU authorities by coordinating team members.
Education
Master of Science - Medicinal And Pharmaceutical Chemistry
Marmara University
Istanbul, Turkey 04.2001 -
Bachelor of Science - Chemistry
Atatürk University
Erzurum 04.2001 -
Software
Timeline
Senior Clinical Research Associate
AstraZeneca
09.2025 - Current
Clinical Research Associate
AstraZeneca Pharmaceuticals
05.2024 - 09.2025
Clinical Research Associate
Fortrea Through AstraZeneca
09.2022 - 05.2024
Clinical Research Associate
ICON DOCS
08.2019 - 10.2021
Technical Documentation and Patent Specialist
World Medicine
05.2019 - 06.2019
R&D Analytical Development Specialist
Deva Holding
06.2013 - 04.2019
Master of Science - Medicinal And Pharmaceutical Chemistry
Marmara University
04.2001 -
Bachelor of Science - Chemistry
Atatürk University
04.2001 -