BUKE KAYALI

• Therapeutic Area: Diabetes, Obesity and Haemophilia
• 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 kept current.
• Provide Local regulatory and legal requirement expertise and payment execution as per local requirements.
• 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 the preparation, handling, and distribution of Clinical Trial Supplies and the maintenance of tracking information. Coordinate logistics for trial supplies.

Managed 8 clinical studies across various phases and project teams, including over 15 CRAs and CTAs, within CDC countries focusing on Rare Diseases, Obesity, and Cardiovascular therapeutic areas. CDC countries include Turkey, Israel, Saudi Arabia, Lebanon, Algeria, Ukraine, and Morocco. Since January 2024, working as CDC-TM assigned to the Rare Diseases therapeutic area.

Key Responsibilities:

• Coordinated trial organization within CDC Turkey countries, including site selection, re-source planning, budget management, risk analysis, and strategy development.
• Ensured compliance and timely communication of trial issues, serving as the key contact for CRAs, GTMs, COM, TA Head, and CDC Director.
• Facilitated communication between HQ, CDC, region, and stakeholders.
• Collaborated with COMs and FM for efficient site feasibility visits and patient recruitment strategies. Worked with SSU for prompt Health Authority approvals.
• Represented CDC Turkey in global study team and investigator meetings.
• Supported onboarding for new CDC PMs and provided regular performance feedback.
• Managed local vendor identification, budget reviews, risk identification and mitigation with global vendors when needed.
• Maintained communication with global study vendors to meet local requirements and address risks.
• Act as SME of Risk based quality management within CDC-Turkey.

Managed Hematology Clinical Studies within Europe Region.

Key responsibilities;

• • Managed and oversaw day-to-day monitoring activities on assigned studies, ensuring CSM deliverables were met by tracking project metrics and deliverable status.
  • Acted as the primary point of contact for CRAs and between Area and Country Leader-ship.
  • Supervise CRAs on ICH/GCP guidelines, regulatory requirements, company SOPs, and therapeutic areas.
  • Ensured all clinical systems were up to date for assigned countries and was responsible for country enrollment targets, site feasibility, selection, and training processes.
  • Conducted risk assessments, mitigation plans, and root cause analyses for issues.
  • Developed and implemented monitoring tools for trials, ensuring consistency across are-as.
  • Provided training on monitoring plans and ongoing non-clinical CRA training.
  • Coordinated with study start-up teams to ensure timely site initiation and was accounta-ble for recruitment across assigned areas/studies.
  • Served as an AdaptiV ambassador, promoting risk-based thinking in trials. Ensured au-dit/inspection readiness at the country/site level, including TMF completeness.

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

Key responsibilities;

• • Maintained control of project budgets and timelines, ensuring teams stayed on task and met schedule targets.
  • Regularly met with the manager to provide detailed project reports and milestone up-dates.
  • Collaborated with project team members to quickly address problems and prepared pro-ject budgets for approval.
  • Worked with the SSU team to create and validate clinical trial documents for EC and HA submissions, ensuring compliance with local requirements.
  • Ensured all necessary documentation and contracts were in place for study commence-ment. Reviewed monitoring reports, assessed recruitment progress, and took actions to meet study milestones and ensure data quality.
  • Submitted required notifications to EC and HA within timelines and managed study-related expenses according to the budget.
  • Kept clinical systems (CTMS, e-TMF) current and completed the archiving process.
  • Established relationships with key vendors to support clinical studies and managed ven-dor communication and budget issues during the study.

• Therapeutic Area:Oncology/Hematology
• CRA role along with local study management role for assigned studies as Local Study Representative.

All CRA tasks included with additional responsibilities listed below.

• Responsible for mentoring CRAs for various aspects of work.
• As LSR, served as key point of contact in country/district for assigned studies. Update CTMS with country-level information: Country-level planning timelines.
• As LSR,ensured successful protocol level execution of start-up, execution, and close out in the country

• Therapeutic Area: Oncology/Hematology
• 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.

• Performed monitoring visits for observational and pase studies related to Pulmonary Hypertension, Malnutrition Rheumatoid Arthritis and Ankylosing Spondylitis.
• Provided all kinds of logistic support and trained sites on study protocol, GCP, clinical trial systems such as EDC, IWRS.

• 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)