Nehir Serife Baykal
Toronto,Canada
Summary
With a career spanning more than 15 years in the clinical research sector, encompassing a tenure of over 5 years as a proficient project manager, I am a seasoned and accomplished professional. My robust academic background, coupled with a remarkable capacity for adaptation, exemplary communication skills, and extensive international experience, facilitated my successful transition to Canada.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Local Trial Manager
Amgen Canada Inc.
Mississauga, Ontario
01.2024 - Current
- Developed and implemented strategies to increase customer satisfaction and loyalty.
- Created monthly reports for senior management summarizing operational performance metrics.
- Coached, mentored and trained team members in order to improve their job performance.
Sr. Clinical Trial Manager
ICON Plc.
Istanbul, TR
04.2022 - 01.2024
- Developed and implemented clinical trial management plans, protocols and reports.
- Organized and managed clinical trials in compliance with ICH-GCP guidelines.
- Reviewed study documents for accuracy, completeness and regulatory compliance.
- Monitored progress of clinical trials, identified problems and developed solutions to ensure timely completion of studies.
- Conducted site selection, initiation visits, monitoring visits and closeout visits as required by the protocol.
- Managed budgeting process including tracking actuals against budgeted costs for each trial.
- Coordinated activities between internal staff members, vendors and third party contractors involved in the execution of clinical trials.
- Reviewed patient data from various sources to identify trends or other important information related to the trial.
- Maintained accurate records of all actions taken throughout the course of each study.
- Evaluated potential new sites for participation in clinical trials based on their qualifications.
- Participated in meetings with sponsors, CROs, investigators, regulatory agencies concerning ongoing projects.
- Presented updates about ongoing studies at internal team meetings and other relevant forums.
Clinical Trial Manager
ICON Plc.
Istanbul, TR
02.2019 - 04.2022
- Created detailed timelines for each project to ensure milestones were met on schedule.
- Provided direction to external vendors such as CROs regarding protocol development, case report forms design, data management systems.
- Participated in meetings with sponsors, CROs, investigators, regulatory agencies concerning ongoing projects.
- Organized and managed clinical trials in compliance with ICH-GCP guidelines.
- Conducted site selection, initiation visits, monitoring visits and closeout visits as required by the protocol.
- Managed budgeting process including tracking actuals against budgeted costs for each trial.
- Reviewed patient data from various sources to identify trends or other important information related to the trial.
- Developed and implemented clinical trial management plans, protocols and reports.
Sr. Clinical Research Associate
IQVIA
Istanbul, TR
06.2014 - 01.2019
- Mentoring CRA
- Conducted site initiation visits, monitored study progress and ensured compliance with ICH and GCP guidelines.
- Performed source document verification, data query resolution and reconciliation of discrepancies.
- Maintained accurate documentation of all on-site activities in the trial master file.
- Provided guidance to junior clinical research associates regarding protocol adherence, CRF completion and other aspects of the clinical trial process.
- Organized investigator meetings; prepared meeting minutes and tracked action items arising from these meetings.
- Monitored safety events reported by investigators or found during monitoring visits.
- Reviewed laboratory results for accuracy prior to database lock.
- Performed pre-study, closeout and interim visits to check on study activities.
- Assessed drug storage conditions and procedures to check adherence to standard protocols.
Associate Manager GFR, Dedicated Line Manager
IQVIA
Istanbul, TR
08.2016 - 02.2017
- Primary Sponsor Contact
- Facilitated the development of staff by providing training, coaching, and feedback.
- Managed daily workflow of team members to meet organizational goals.
- Collaborated with senior management to develop annual operational plans.
- Conducted regular performance reviews with direct reports.
- Implemented customer service standards across all departments in the organization.
- Monitored customer complaints and provided timely solutions to improve customer experience.
- Resolved conflicts between employees or customers in a professional manner.
- Oversaw inventory levels, making adjustments as needed based on sales trends.
Clinical Research Associate
CRM CRO
Istanbul, TR
06.2012 - 05.2014
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Coordinated the submission of regulatory documents to IRBs and ECs and other relevant authorities.
- Assessed incoming source documentation for accuracy and completeness against case report forms.
- Ensured proper storage of investigational product at investigator sites per GCP guidelines.
- Monitored safety events reported during the course of clinical trials in accordance with SOPs.
- Ensured timely completion of all deliverables by tracking project timelines and milestones.
- Provided training on GCP standards to new personnel or existing staff members.
- Performed pre-study, closeout and interim visits to check on study activities.
Research Assistant in OB & Gyn
Yale University Medical School
New Haven, USA
08.2009 - 08.2011
- A Class publications and posters.
- Prepared comprehensive reports summarizing research findings.
- Performed literature reviews to ensure accuracy of results.
- Assisted in the design and implementation of experimental protocols.
- Provided support for faculty members with grant applications related to research projects.
- Managed multiple research projects simultaneously while ensuring accurate record keeping.
- Utilized knowledge of scientific principles and techniques to troubleshoot problems encountered during the course of research.
- Presented findings at professional conferences or seminars as required by faculty supervisors.
- Prepared reports, presentations and articles using Microsoft Word and PowerPoint.
- Conducted qualitative and quantitative analysis on assigned data.
- Created graphs, spreadsheets and presentation slides to help researchers present findings.
- Set up, calibrated and maintained laboratory and field research equipment for requirements of study.
- Organized, labeled and stored study biospecimens.
Education
Master of Science - Cellular Biology And Histology
Dokuz Eylul University, Histology And Embryology
08.2011
Bachelor of Science - Biology
Suleyman Demirel University, Biology
Isparta, TR07.2007
Skills
- Cross-Functional Leadership
- Excellent Team Spirits
- Excellent Organization Planning
- Comprehensive Knowledge ICH-GCP
- Multi-Tasking
- Problem Solver
- Independent Decision Maker
- Project Management
- People Management
- Risk Management
- Cross-Functional Teamwork
- Team Leadership
- Negotiation
- Staff Training and Development
Affiliations
- Yoga Alliance Trainer
- Reiki 2 Master
Accomplishments
- Team Collaboration Award
- FSA Award
Certification
- Yoga Alliance Teacher Training Certificate (2019)
Timeline
Local Trial Manager
Amgen Canada Inc.
01.2024 - Current
Sr. Clinical Trial Manager
ICON Plc.
04.2022 - 01.2024
Clinical Trial Manager
ICON Plc.
02.2019 - 04.2022
Associate Manager GFR, Dedicated Line Manager
IQVIA
08.2016 - 02.2017
Sr. Clinical Research Associate
IQVIA
06.2014 - 01.2019
Clinical Research Associate
CRM CRO
06.2012 - 05.2014
Research Assistant in OB & Gyn
Yale University Medical School
08.2009 - 08.2011
Master of Science - Cellular Biology And Histology
Dokuz Eylul University, Histology And Embryology
Bachelor of Science - Biology
Suleyman Demirel University, Biology
Similar Profiles
Carole CanaanCarole Canaan
Account Development Representative at Amgen CanadaAccount Development Representative at Amgen Canada
Rashmi KumariRashmi Kumari
Project Manager at Indegene Limited - Astrazeneca (UK), Amgen (EU)Project Manager at Indegene Limited - Astrazeneca (UK), Amgen (EU)
RISHIKA RANGURISHIKA RANGU
Associate Data Engineer (Level - 3) at AmgenAssociate Data Engineer (Level - 3) at Amgen
Andrea Lira SanmiguelAndrea Lira Sanmiguel
AUDIO MIXER & BOOM OPERATOR at Toronto Film SchoolAUDIO MIXER & BOOM OPERATOR at Toronto Film School
Mohammad Zahir NasratMohammad Zahir Nasrat
Admin/Finance Officer at NWARA-CPMOAdmin/Finance Officer at NWARA-CPMO