Sergey Tabakov Email & Phone Number

Using my expertise in gap analysis and fraud/misconduct investigation, as well as my ability to drive process improvements based on ISO 9001 principles, I have successfully enhanced client productivity levels and delivered the positive results across a range of GCP audits of the investigator sites, FDA Mock Inspection audits, Vendor selection audits, GDP audits of warehouse, ISO 9001:2015 QMS audits of organizations, audits of SOPs for data management and biostatics, and Independent Ethics Committee (IEC).I have worked in various countries, including Russia, Belarus, Egypt, Georgia, Turkey, Thailand and France, gaining valuable experience in different regulatory environments and cultural contexts.

I have successfully enhanced client productivity levels and delivered the positive results across a range of GCP audits of the investigator sites and Vendor selection audits.

Russian Federation

Successfully adapted company Standard Operating Procedures (SOPs) to align with ICH GCP (R2) and Quality Management System (QMS) principles.Planned, executed, and reported GCP audit and Quality Oversight Monitoring Visits to ensure compliance with GCP and other applicable regulations.Provided training on GCP, Quality Assurance (QA), patient recruitment, and engagement to new company staff and site teams, ensuring adherence to best practices and regulatory requirements.

Successfully performed various types of investigator site visits, including initiation, interim, and close-out visits, ensuring high-quality data collection and compliance with protocols and regulations.Played a key role in the preparation for and assistance during audits and inspections at investigator sites, contributing to successful outcomes and recognition from regulatory authorities.Contributed to the development and maintenance of the company's quality management documentation related to the work of Clinical Affairs, ensuring adherence to best practices and facilitating regulatory compliance.

Russian Federation

Successfully performed various types of investigator site visits, including initiation, interim, and close-out visits, ensuring high-quality data collection and compliance with protocols and regulations.Played a key role in the preparation for and assistance during audits and inspections at investigator sites, contributing to successful outcomes and recognition from regulatory authorities.Conducted effective co-monitoring visits to investigator sites, identifying and addressing issues in a timely and proactive manner to maintain the quality and integrity of the studies.Successfully trained and supervised Entry Level CRAs, supporting their professional development and contributing to a strong and skilled clinical research team.Contributed to the development and maintenance of the company's quality management documentation related to the work of Clinical Affairs, ensuring adherence to best practices and facilitating regulatory compliance.

Successfully collected and reviewed Site Regulatory Documents, performing primary Quality Control to ensure accuracy and completeness.Played an instrumental role in the preparation for and assistance during audits and inspections at investigator sites, helping to achieve positive outcomes and high levels of compliance.Conducted effective co-monitoring visits to investigator sites, identifying and addressing issues proactively to maintain the quality and integrity of the studies.Supervised and trained Entry Level CRAs, contributing to the development of a skilled and capable clinical research team.Conducted training sessions for study team members, facilitating their professional development and enhancing their knowledge and skills.Contributed to the development and maintenance of the company's quality management documentation related to the work of Clinical Affairs, ensuring adherence to best practices and regulatory requirements.

Russia

Conducted medical treatment, including diagnosing and treating internal diseases and providing emergency care.Committed to ongoing learning to provide the highest level of care to patients.

General Practitioner, Medicine, Doctor

Intership, General Practic

Clinical Pharmacology, Medicine, Doctor

Intership, The Physician Of Emergency Care

Intership, Public Health Organization

Medical Degree, Medicine

Basic School Education, Medical-Biological