Stanislav Vavilov

• To serve as Global Lead Auditor/Project Lead on international projects and coordinate the workload of other auditors assigned to the project. • To schedule, conduct, and document assigned GCP audits. Specific audit areas are include: Investigator Sites, Trial Master and Project Management Files, Documents, Data Management Activities and Files, Safety Reporting, Final Study Reports, and Vendors.

• Scheduling, conducting, and documenting assigned GCP audits. Specific audit areas included: Investigator Sites, Trial Master and Project Management Files, Documents, Data Management Activities and Files, Safety Reporting, Final Study Reports, and Vendors. • Providing consultancy on quality and regulatory related issues. • Developing and updating Quality Management Documents (policies, SOPs, WI).

• Preparing annual audit plan. • Scheduling, conducting, and documenting internal GCP audits of investigator sites, Trial Master Files, and Server Files. • Preparing sites for regulatory authority inspections. • Developing and updating SOPs and WI in Clinical Research Department. • Training new CRAs.

• Identifying sites in Russia and Ukraine. • Preparing clinical trials initiation in Brazil and Colombia. • Preparing and signing contracts with sites and vendors. • Monitoring of investigator sites in Russia

Increasing sales of Key Products

Increasing sales of Key Products

Increasing sales of Key Products