BUKE KAYALI

Managed 8 clinical studies with various phases and project teams, including over 15 CRAs and CTAs, within CDC countries focusing on Rare Diseases, Obesity, and Cardiovascular TAs. CDC countries includes Turkey, Israel, Saudi Arabia, Lebanon, Algeria, Ukraine, and Morocco. Since January2024, working CDC-TM assigned to Rare Diseases TA.

Key Responsibilities:

• Overall trial organization and coordination within CDC Turkey countries, including assessing site selection, planning resources and budget, conducting risk analysis, and developing strategies for trial implementation.
• Ensured compliance with applications, timely and accurate communication of trial issues, and functioned as the key point of contact for Clinical Research Associates (CRAs), Global Trial Managers (GTMs), Clinical Operations Manager (COM), TA Head, and CDC Director.
• Facilitated effective communication of all trial/project-related issues between HQ, CDC, region, and other internal/external stakeholders. Collaborated with COM and CDC Feasibility Manager (FM) to ensure efficient and accurate site feasibility visits, including analysis of site logistics, site personnel performance/quality indicators, and accountability for patient recruitment strategies.
• Worked in collaboration with Study Start-Up (SSU) to organize prompt Health Authority approval by making timely submissions and providing responses as requested.
• Represented CDC Turkey in relevant study team meetings and organized investigator meetings.
• Supported onboarding for new CDC Project Managers (PMs), enabling them to effectively learn tasks and job duties.
• Regularly evaluated employee performance and provided feedback.
• Managed local vendor identification with relevant stakeholders as per study requirements, conducted regular budget reviews, identified vendor-related risks, and prepared mitigation plans for assigned countries of the study.
• Maintained close communication with global study vendors to meet local requirements, identify risks, and develop mitigation plans in collaboration with the global study team.

Managed Hematology Clinical Studies within Europe Region.

Key responsibilities;

• Managed and oversee day-to-day monitoring activities on assigned studies to ensure CSM deliverables are met by tracking and maintaining project metrics and status of deliverables.
• Be primary point of contact for CRAs for study and site questions and between Area and Country Leadership
• Ensured all clinical systems are up to date for assigned countries
• Responsible for country enrollment target and accountable site feasibility, selection and training process.
• Conducted trending, assessment of risk, mitigation plans, root cause analysis for issues and emerging issues.
• Developed monitoring tools for trial, drive implementation and ensure consistency across area.
• Provided monitoring plan training and ongoing non-clinical CRA training.
• Liaise with study-start-up to ensure timely site start-up. Accountable for recruitment across assigned areas/studies and collaborate with other ASMLs/GSML to accomplish recruitment for trial.
• Served as AdaptiV ambassador ensuring implementation and ensuring risk-based thinking on trial.
• Ensured audit/inspection readiness at country/site level, incl. TMF completeness.
• Maintained knowledge of ICH/GCP, regulatory requirements, company SOPs, therapeutic area (protocol,amendments).

Managed 6 clinical studies (Rare Diseases) and project teams including CRAs and CTAs within MEA region (UAE,Pakistan,Egypt,Lebannon,Saudi Arabia,Qatar).

Key responsibilities;

• Maintained tactical control of project budgets and timelines to keep teams on task and achieve schedule targets.
• Met with manager regularly to provide detailed project report and milestone updates.
• Partnered with project team members to identify and quickly address problems.
• Prepared and obtain approval for project budgets, including all expenses related to project.
• Collaboratedd with SSU team to create clinical trial documents required for EC and/or HA submission.
• Validated technical and administrative documents necessary for study and ensure corporate documents comply with local requirements.
• Ensured all necessary documentation is in place for commencement of study.
• Ensured contracts with revolving funds regarding investigator fees and third parties are duly signed.
• Reviewed monitoring reports, assess recruitment progress, and take necessary actions to address study-specific milestones and ensure data quality.
• Submitted all required notifications (protocol amendment, periodic reports, annual progress reports, etc.) to EC and HA within required timelines.
• Managed study-related expenses in alignment with planned budget.
• Ensured that clinical systems(CTMS,e-TMF) kept current and successfully completion of archiving process.
• Identified and established relationships with key vendors to support the clinical studies' overall strategy and goals as local and regional level. Manage vendor communication and budget related issues during study conduct.

• Had senior CRA role in oncology/hematology studies.
• Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
• Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
• Responsible for mentoring CRAs for various aspects of work.
• As LSR, served as key point of contact in country/district for assigned study. Update CTMS with country-level information: Country-level planning timelines.
• Ensured successful protocol level execution of start-up, execution, and close out.
• Ensured site related study execution including but not limited to monitoring visits, site evaluations, selection,activation, and close out and visit.
• Ensured clinical trial management systems containing all site-specific information are maintained and kept current.
• Provided Local regulatory and legal requirement expertise and payment execution as per local requirements.
• Ensured audit and inspection readiness of assigned sites.

• Had CRA role in oncology/hematology studies
• Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
• Ensure successful protocol level execution of start-up, execution, and close out.
• Ensure site related study execution including but not limited to monitoring visits, site evaluations, selection,activation, and close out and visit.
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current.
• Provide Local regulatory and legal requirement expertise and payment execution as per local requirements.
• Ensure audit and inspection readiness of assigned sites.

• Have CRA role in diabetes, obesity and hemophilia clinical studies.
• Ensure successful protocol level execution of start-up, execution, and close-out.
• Ensure site related study execution including but not limited to monitoring visits, site evaluations,selection, activation, and close out visit.
• Ensure clinical trial management systems containing all site-specific information are maintained and keptcurrent.
• Provide Local regulatory and legal requirement expertise and payment execution as per localrequirements.
• Ensure audit and inspection readiness of assigned sites.

• Provide support for updating and maintaining clinical systems that track site compliance and performance within project timelines. (electronic and physical TMF)
• Prepare and submit regulatory authority/ethics committee applications
• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist CRAs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information- Coordination of logistics for trial supplies

• Performed monitoring visits for observational studies related to Pulmonary Hypertension, Malnutrition ,Rheumatoid Arthritis and Ankylosing Spondylitis.
• Provided all kinds of logistic support and training support to the assigned sites.

• Data capture, reporting & management of Transparency Project (HCP/HCO Spend as per EFPIA Code)
• Coordination between relevant directors (Legal, OEC, Finance etc.), managers & data resources
• Correspondence with regional & global functions
• Active participation in meetings (cross-functional & international)