Canset Sonmez Kizkun
Senior Global Project Manager
Istanbul,Turkey
Summary
With 17 years of experience in clinical trials, including 5 years as a clinical research associate, I have developed a strong foundation in the field. Throughout my career, I have held various management roles within multinational pharmaceutical companies and CROs. Expertise extends to international Phase I to Phase IV Clinical Studies, Observational Studies, and Early Access Programs across Turkey, Europe, and North America. Pride in end-to-end responsibilities encompassing business and strategy development, study design, team and project management. Approach is holistic, prioritizing customer satisfaction, financial and project milestones, and quality assurance. Professional seeking challenging leadership roles with colleagues describing me as collaborative with a knack for creative solutions. Strongest qualifications lie in strategic thinking, decision-making, and the ability to create high-performing teams.
Overview
17
17
years of professional experience
2
2
Languages
Work History
Senior Global Project Manager
Accelsiors CRO
Istanbul, Istanbul
12.2021 - Current
- Provide project leadership and direct/manage project deliverables from beginning to end
- Define project scope, goals, and deliverables supporting project delivery in collaboration with the Sponsor and all project stakeholders
- Effectively communicate project goals, and scope including task ownership matrix, budget, timelines, risks, and quality parameters to team members and stakeholders in a timely and clear fashion (Kick-Off Meeting and during planned Project Team meetings)
- Actively project/monitor the resources required to achieve the project goals based on the project budget and real-time project scope/status
- Determine and assess the need for additional staff and/or consultants and make the appropriate recruitment if necessary, during the project cycle
- Plan and schedule project timelines and milestones using appropriate tools
- Determine the frequency and content of status reports from the project team, analyze results, and risk assess/address problem areas
- Proactively manage changes in project scope, identify potential risks, and engage contingency plans
- Define project success criteria and disseminate them to involved parties throughout the project lifecycle
- Coach, mentor, motivate, and supervise project team members and contractors, and influence them to take positive action and accountability for their assigned work
- Build and develop business relationships vital to the success of the project including proposal input and support for bid defense meetings
- Conduct project post-mortems through ‘Lessons Learned' meetings and create recommendations to identify successful and unsuccessful project areas and propose process improvements
- Develop best practices and tools for project execution and management
- Coached junior team members for professional development and increased retention rates within the department.
- Delivered high-quality results on complex global projects through meticulous planning, organization, and execution.
- Led change management initiatives to ensure smooth transitions during organizational restructuring or process improvements.
- Implemented best practices in global project management to increase efficiency and streamline operations across all projects.
- Improved cross-functional team collaboration through effective communication strategies and regular progress meetings.
- Monitored project progress, identified risks and took corrective action as needed.
Head Of Clinical Operations
Ascot Science CRO
11.2016 - 12.2021
- Responsible for defining operational strategy and execution of the clinical operations strategy of the project on a regional level
- Plan, initiated, conduct, and close out clinical studies in compliance with quality standards & defined timelines
- Lead cross functional study team, Lead Clinical Study Team Meetings, actively manage and track study milestones and critical path activities
- Tracking and manage overall execution of clinical studies
- Focusing on budget planning, timelines, contracts, and quality issues
- Vendor selection, management and oversight of external vendors in compliance with Ascot/Sponsor's processes and procedures and the applicable regulation
- Effectively communicate management strategies, policies, and procedures in conjunction with leadership teams
- Attending meetings with sponsors, vendors, regulatory authorities, and healthcare professionals (KOLs), coordinating the collaboration of the cross-functional departments, as well as with third-party vendors and subcontractors, to ensure the achievement of project deliverables
- Responsible for guaranteeing customer satisfaction
- Plans and implements action items for anticipated and unexpected risks to achieve project deliverables
- Performance, staff utilization, and headcount management (Project Managers, CRAs & Study Start-up Teams)
- Directs technical and operational aspects of the project to ensure compliance with regulatory regulations and SOPs
- - The establishment of the Clinical Operations Department in Turkey made Turkey a hub country for the EMEA Region
Senior Clinical Project Manager
Johnson&Johnson/ Through PRA Health Science
Istanbul, Istanbul
01.2016 - 11.2016
- Responsible for project management of the assigned studies: proactively plans, drives, and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution, and closeout
- Responsible for the supervision of assigned direct reports
- Regional Project Management Mentor for Assigned 5 different Countries (Russia, Israel, Poland, Ukraine, Romania) and Leading regional project meetings for assigned studies
- Perform Country Selection Feasibility Visits for Oncology and Cardiology Studies
- Globally first site activation in Psychiatry Phase II trial
- Regional Leading to Finance and IT departments for Site and Investigator Payment System Development
- Assist to Global Project Manager to Identify country start-up strategies
- Enhanced patient recruitment and retention strategies, leading to increased enrollment numbers and reduced dropout rates.
- Built strong relationships with key opinion leaders in therapeutic areas relevant to company''s product pipeline, leveraging their expertise to inform study design decisions.
Local Trial Manager
Johnson&Johnson
Istanbul, Istanbul
02.2015 - 01.2016
- Responsible for management of clinical studies from feasibility and start-up process to the close-out phase
- Responsible management of site selection, submission, initiation, execution and quality of all clinical trials
- Responsible to leading the CRAs and CTAs
- Performing protocol and site feasibility visits
- Establishment and management of the country project budget
- Review Monitoring Visits Reports and escalates performance issues and training needs to CRA and/or functional vendor and internal management as needed
- Management of Trial Master File and Study Timelines as per Company Metrics
- Management of First Local Observational Oncology Study in Turkey
- Over recruitment in the cardiovascular mega trial
- Presented Key Success Items of this trial as 'Best Practice' during the Global Investigator Meeting
- Management of EC/HA submissions of 2 psychiatry and 2 oncology trials; No revision to all of the MoH study applications/ submissions
- All 4 submissions were approved within the limits of targeted timelines
Clinical Project Manager
MSD Turkey
Istanbul, Istanbul
08.2012 - 01.2015
- Managing all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met
- Management of site selection, EC/HA submissions, site initiation, and close-out planning
- Reviewing monitoring reports
- People Management of 5 CRAs and 2 CTAs and 10 Site Coordinator
- Managing study-related vendors and serving as the primary point of contact for contracted CROs, study staff, and contract labs; identifying potential risks and resolving issues with CROs; establishing vendor management plans and reviewing quality metrics
- -Management of Turkey's First Pediatric Oncology Phase II Clinical Trial (Most Recruiting Country)
- -First EC/HA approval and first site activation in the EEMEA region (Phase II Vaccine Study)
- -Over recruitment in Hematology Phase III Clinical Trial
- -1 Audit was performed on 1 study under responsibility and completed with no recommendation at all
Clinical Research Associate
Roche Pharmaceuticals
02.2008 - 08.2012
- Performed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
- Act as a mentor for new clinical staff including conducting co-monitoring and training visits
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Managing the budget of clinical trials, working in cooperation and coordination with Marketing and Medical Departments
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Performed oversight of the clinical drug supply process
- Prepared all documents required for IEC approval and other relevant documents & Close follow-up with the IEC approval process
- CRO/ Vendor Management
- -Affiliate award, 'Employee who makes a difference'
- -Globally first patient enrollment
- -Globally most recruiting countries (Presented as Best Practice in EEMEA Region)
- -First Local Phase II-III trials in Romatology and Hematology
- -2 Audit performed to 2 studies under my responsibility and completed with no recommendation at all
Education
Bachelor of Science - Biology
Anadolu University
Eskişehir, Turkey 09.2021 - 06.2006
Skills
Team collaboration
Decision-making
Excellent communication
Creative thinking
Team leadership
Problem-solving abilities
Problem-solving
Strategic thinking
Cross-cultural communication
Remote team management
Adaptability and flexibility
Verbal and written communication
Customer relationship management
Timeline
Senior Global Project Manager
Accelsiors CRO
12.2021 - Current
Bachelor of Science - Biology
Anadolu University
09.2021 - 06.2006
Head Of Clinical Operations
Ascot Science CRO
11.2016 - 12.2021
Senior Clinical Project Manager
Johnson&Johnson/ Through PRA Health Science
01.2016 - 11.2016
Local Trial Manager
Johnson&Johnson
02.2015 - 01.2016
Clinical Project Manager
MSD Turkey
08.2012 - 01.2015
Clinical Research Associate
Roche Pharmaceuticals
02.2008 - 08.2012
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