Екатерина Холодкова

• Develop and improve data management processes to ensure delivery of high quality clinical management• Supervise external data management vendors in contract data management activities • Participate in the development of budget and timelines for clinical studies• Work with CROsIT companies in developing contractual agreements and partnership.• Communicate with investigators, clinical research associates, programmers and statisticians regarding data management issues• Assign Data Management Department employees for Data Management Projects• Ensure complete and accurate documentation for all data management activities• Provide input for finalizing protocols, case report forms, data management plans, and clinical study reports• Provide input for Data Management software setup and validation• Develop SOPs for data management activities• Train and supervise Data Management Department staff • Work with QA to ensure data management processes are GCP and GCDMP compliant through appropriate evaluation and auditing functions