Hüma Tuğçe Sezgin Günay
Start -Up Lead 2
Istanbul,34
Summary
Throughout my career, I have accumulated extensive experience in Regulatory and Start Up with clinical trial sectors. During my tenure in the clinical trials sector, I have gained valuable insights into the intricacies of managing start up and maintenance projects, navigating regulatory requirements and driving successful outcomes. Also I have gained, proven track record of success in leading teams and projects in fast-paced start up environments and strong communication and leadership skills,with a passion for driving innovation and achieving exceptional results.
Overview
8
8
years of professional experience
2
2
Languages
Work History
Start -Up Lead 2
ICON Strategic Solutions
05.2022 - Current
- Perform quality review of country and site level essential documents following a risk-based approach, issue queries, and communicate outcome to identified users at key milestones and during the course of the study
- Prepare and submit Regulatory and IRB/IEC documentation as required per country requirements and Bayer QSDs during the course of the study
- Preparation, tracking, and distribution of site start up documentation including Investigator Site File
- Obtain any required approvals for relevant site document (e.g. informed consent, financial disclosures) to ensure start up timelines are met
- Manage oversight, in collaboration with CLM, of country and site start up activities and eTMF quality using Vault Clinical reports and dashboards
- Monitor internal start up KPIs across studies and identify and communicate trends
- Support start-up process improvement implementation
- In collaboration with CRA, maintain and ensure accuracy of site information in Vault
- Assist with audits/inspections of relevant start up activities and/or eTMF
- Attend and actively participate in team meetings by providing site greenlight projections and timelines
- Provide input on site activation strategy
- Ensure awareness of related local regulations and support maintenance of country intelligence in Veeva
Regulatory & Start Up Specialist 1
IQVIA
06.2021 - 05.2022
- Local Regulatory Affairs Expert Amgen FSP Model
- Collected, reviewed, organized and assembled regulatory start-up submissions; interacted with regulatory agencies
- Increased start-up efficiency by streamlining processes and implementing organizational systems.
- Tracked submissions and ensure timely filing of documents
- Ensured that all assigned start up activities are on tracked and supported study deliverables
- Provided accurate projections and timelines to study teams agreed with Sponsor
- Reviewed and customized country and site-specific patient informed consent forms, patient documents for compliance with local requirements and control central IRB Submission package
- Mentored CTA Team on leadership skills, strategic planning, and team building to drive long-term success.
Sr. Site Management Coordinator
IQVIA
11.2020 - 06.2021
- Collected, reviewed, organized and assembled regulatory start-up submissions; interacted with ethics committees and regulatory agencies
- Tracked submissions and ensure timely filing of documents
- Ensured that all assigned start up activities are on tracked and supported study deliverables
- Provided accurate projections and timelines to study teams agreed with Sponsor
- Reviewed and customized country and site-specific patient informed consent forms, patient documents for compliance with local requirements
- Negotiated site contracts and budgets with sites
- Negotiated contracts and budgets with investigative sites; and Collaborated with internal project team to ensured negotiations occur within timelines.
- Prepared safety submissions
- Reviewed and customized country specific labels for compliance with local requirements
- Followed up site's routine and ad-hoc payments Interacted with investigational sites and vendors during their payment process
Site Management Coordinator
IQVIA
05.2019 - 11.2020
- Collected, reviewed, organized and assembled regulatory start-up submissions; interacted with ethics committees and regulatory agencies
- Tracked submissions and ensure timely filing of documents
- Ensured that all assigned start up activities are on tracked and supported study deliverables
- Provided accurate projections and timelines to study teams agreed with Sponsor
- Reviewed and customized country and site-specific patient informed consent forms, patient documents for compliance with local requirements
- Negotiated site contracts and budgets with sites
- Negotiated contracts and budgets with investigative sites; and Collaborated with internal project team to ensured negotiations occur within timelines.
- Prepared safety submissions
- Reviewed and customized country specific labels for compliance with local requirements
- Followed up site's routine and ad-hoc payments
- Interacted with investigational sites and vendors during their payment process
Research and Development Assistant
Triogen Biotechnology
12.2016 - 05.2019
- R&D consultancy in state and industry supported projects
Assistant Researcher
University Of British Columbia, BC Cancer Agency
06.2016 - 09.2016
- The main research topics of Innate Immune System. During my research, I studied especially “Gender differences in innate lymphoid cells and asthma“.My supervisor is Prof. Dr Fumio Takei (Takei Lab)
Education
Master of Science - Medical Biology And Genetics
Istinye University
Istanbul, Turkey 04.2001 -
Bachelor of Science - Genetics And Bioengineering
Istanbul University
Istanbul, Turkey 04.2001 -
High School Diploma -
Bakırköy Anatolian High School
Istanbul, Turkey 04.2001 -
Skills
Timeline
Start -Up Lead 2
ICON Strategic Solutions
05.2022 - Current
Regulatory & Start Up Specialist 1
IQVIA
06.2021 - 05.2022
Sr. Site Management Coordinator
IQVIA
11.2020 - 06.2021
Site Management Coordinator
IQVIA
05.2019 - 11.2020
Research and Development Assistant
Triogen Biotechnology
12.2016 - 05.2019
Assistant Researcher
University Of British Columbia, BC Cancer Agency
06.2016 - 09.2016
Master of Science - Medical Biology And Genetics
Istinye University
04.2001 -
Bachelor of Science - Genetics And Bioengineering
Istanbul University
04.2001 -
High School Diploma -
Bakırköy Anatolian High School
04.2001 -