Ketevan Mchedlishvili
Senior Clinical Site Lead | Merck KGaA
Tbilisi
Summary
Accomplished Medical Doctor with over 10 years of progressive experience in clinical research and medical affairs, currently serving as a Senior Clinical Site Lead. Demonstrated success in managing global clinical trials across Endocrinology and Immuno-Oncology, with a strong focus on site enablement, regulatory compliance, and stakeholder engagement. Skilled in leading cross-functional teams, driving operational excellence, and ensuring trial quality from start-up through execution. Adept at engaging with KOLs, conducting scientific exchange, and aligning strategies with sponsor requirements. Known for proactive collaboration, team motivation, and delivering high-quality project outcomes. Well-versed in international regulatory frameworks including GCP, ICH, FDA, and EMA.
Overview
15
15
years of professional experience
Work History
Senior Clinical Site Lead
Merck KGaA Healthcare R & D, Strategy & Business Operations
05.2024 - Current
- Led site operations across six countries, optimizing trial performance and compliance.
- Implemented risk-based monitoring and recruitment strategies aligned with global goals.
- Ensured GCP/ICH adherence and coordinated with CROs and regulatory agencies.
- Managed project timelines, ensuring successful completion within budget and on schedule.
- Developed effective communication channels between onsite teams and offsite management staff.
Endocrinologist
David Tatishvili Medical Center Ltd
05.2016 - Current
- Medical Care for patients with Endocrine disorders.
- Monitor patient progress or responses to treatments.
- Demonstrated leadership by making improvements to work processes and helping to train others.
Regional Medical Director
ARENSIA Exploratory Medicine GmbH
11.2021 - 05.2024
- Supervise clinical staff, providing continuous professional development opportunities and training to maintain and strengthen competencies.
- Oversee day-to-day practice functions, patient care, medical and administrative staff, and business activities.
- Develop and actualized strategies to maintain the highest standards of care.
- Create plans to achieve organizational goals, promote employee welfare, and deliver quality patient care.
- Maintain good communication between department heads, medical staff, and by attending/setting up meetings and synchronizing interdepartmental functioning.
- Provide Medical and scientific input on trial protocols.
- Protect data safety and integrity of the trial participants throughout the trial.
Sr. SSU and RSU Specialist
IQVIA / Medpace, Inc. / Biomapas LLC
01.2021 - 11.2021
- Coordination and oversight of the SSU and RSU teams.
- Participation in the process of selection of new SSU and RSU employees.
- Training and mentoring newcomers and junior SSU and RSU specialists.
- Helping and advising SSU employees to solve various clinical trial start-ups and documentation-related issues, CAPA resolution, BD, and Client consultation.
- Ensuring high-quality service is provided to clients.
- Confirming submission strategy and timelines for the initial study submission/approval and amendments submission/approval during the study duration.
- Acting as a key expert on local requirements.
- Coordinating communication with applicable Authorities and responding to their queries raised.
CRA Line Manager
Biomapas LLC
01.2021 - 11.2021
- Management of Clinical Research Associates (CRAs), including leading weekly project calls, initial and continued training, and development of CRAs.
- Oversight and Management of CRAs to ensure CRAs are meeting expectations of core responsibilities.
- Participation in the process of selection of new CRAs.
- Mentoring newcomers and junior CRAs.
Senior Clinical Research Associate / Lead CRA
IQVIA / Medpace, Inc. / Alimentiv Inc. / Biomapas LLC
05.2016 - 01.2021
- Managing turnover and retention of CRAs to meet company objectives.
- Working successfully with a diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Motivating and encouraging team members to communicate more openly and constructively with each other.
- Planning and completing group projects, working smoothly with others.
- Demonstrating leadership by making improvements to work processes and helping to train others.
- Recognizing by management for providing exceptional customer service.
Senior Clinical Research Associate
ICON / CromosPharma LLC
12.2012 - 05.2016
- Performing clinical trial selection, initiation, monitoring, and close-out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
- Developing and implementing innovative approaches for site selection, and pre-study activities to identify and evaluate potential investigators.
- Assisting with the development of study-specific monitoring plans, annotated CRFs, monitoring conventions, tracking forms, and other study-related documents/tools.
- Developing patient enrollment strategies with the project team and study sites.
- Conducting and assisting with Project specific administrative activities as a member of the project team.
Clinical Research Associate
06.2011 - 12.2011
- Continuously monitoring active studies to verify compliance with the facility's protocols and regulatory standards, helping to protect personnel from legal issues.
- Identifying problems with study protocols and working with investigators to resolve the issues.
- Developing and implementing recruitment strategies to attract ample participation.
- Coordinating investigators by reviewing and maintaining records of qualification for research.
Clinical Research Coordinator
01.2011 - 06.2011
- Assisting the Director of Clinical Operations, Project Director, Sr. Clinical Research Associates in organizing and supervising the conduct of Clinical Trials.
- Participating in activities for improvement of quality of work, processes, and procedures in order to achieve continual improvement in the quality of services and to provide recommendations for quality improvement.
Junior Doctor
01.2010 - 06.2011
- Assuring that all procedures in a study are performed with the appropriate level of supervision and only by individuals who are licensed or otherwise qualified to perform.
- Performing study-related procedures.
- Making important study-related decisions in compliance with the ethical conduct of the study.
- Performing medical, psychological, or other support that subjects might require during or as a consequence of their participation in the study. Protecting the rights, safety, and welfare of participants.
Education
Certificate of Achievement - Immunology - Immuno-oncology
Harvard Medical School
Graduate Certificate - Certified Program in General Management
Georgian Institute of Public Affairs (GIPA)
Residency Degree - Endocrinology
Tbilisi State Medical University (TSMU)
The Academic Degree - Medical Doctor
Tbilisi State Medical University (TSMU)
Nurse - TSMU Diploma - undefined
Tbilisi State Medical University (TSMU) College
Skills
Clinical Trial Management (Phase I–IV, global trials)
Medical staff leadership
Strong Communication, Presentation, and Negotiation Skills
Problem-Solving
Treatment planning oversight
Process improvement
Recruit well-qualified staff
Business operation management
Quality control
Timeline
Senior Clinical Site Lead
Merck KGaA Healthcare R & D, Strategy & Business Operations
05.2024 - Current
Regional Medical Director
ARENSIA Exploratory Medicine GmbH
11.2021 - 05.2024
Sr. SSU and RSU Specialist
IQVIA / Medpace, Inc. / Biomapas LLC
01.2021 - 11.2021
CRA Line Manager
Biomapas LLC
01.2021 - 11.2021
Endocrinologist
David Tatishvili Medical Center Ltd
05.2016 - Current
Senior Clinical Research Associate / Lead CRA
IQVIA / Medpace, Inc. / Alimentiv Inc. / Biomapas LLC
05.2016 - 01.2021
Senior Clinical Research Associate
ICON / CromosPharma LLC
12.2012 - 05.2016
Clinical Research Associate
06.2011 - 12.2011
Clinical Research Coordinator
01.2011 - 06.2011
Junior Doctor
01.2010 - 06.2011
Graduate Certificate - Certified Program in General Management
Georgian Institute of Public Affairs (GIPA)
Residency Degree - Endocrinology
Tbilisi State Medical University (TSMU)
The Academic Degree - Medical Doctor
Tbilisi State Medical University (TSMU)
Nurse - TSMU Diploma - undefined
Tbilisi State Medical University (TSMU) College
Certificate of Achievement - Immunology - Immuno-oncology
Harvard Medical School
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