Clinical Compliance & Training activities
- Quality Management system – development, implementation, maintains, effective work, including co-monitoring visits, QA visits to investigational sites and vendors, for cause data analysis, standardization of working processes for Dept Management Monitoring checks/ Self inspections of key clinical operational activities according to risks analysis and risks grades. Documentation of results, CAPA management, processes improvement, training on MM checks results locally and globally for staff awareness, sharing knowledge and prevention of trends with the same issues. Communication/ escalation of results, CAPAs, trends, metrics to upper management.
Contribution to global quality management process – review of global SOPs, authoring of MM check/ self-inspections templates (IMP management, Green Light)
- Risk Register, Quality Plan, Quality Tracker development, posting at required resources, updates. Review of Quality trackers for other countries coordination and oversight.
- SOP administration – Local SOP writing, update, maintains
- Training on GCP, SOPs, safety – development of training materials for local and global level, delivery to internal and external staff, results analysis, feedback providing, identification areas for further improvement. Newcomers onboarding training. Advanced GCP courses for experienced staff
- CRO/ Vendor oversight - CRO provision with GSK systems access – RAA, soft tokens management, Citrix, technical issues solving. Oversight of local Depots, Local Archive – annual quality visits, quality visits/audit reports, risk identification and finding classification, route cause, CAPA management.
- Performance/ Monitoring Metrics Management/ Self inspections - Business systems Local Expert - Veeva - CTMS, eTMF, regular metrics review, analysis, provision data to Dept staff, issue identification, ways а improvement.
- Audits – supported more than 30 study site audits, about 10 different system audits (Medical Department), 1 CRO audit (asthma trial with CRO monitoring) , Local Depot assessments, 2 for cause audit, 4 FDA inspections (6 sites). CAPA management after the audits, communication with auditors and stakeholders, deadlines tracking
CRA/ Project Manager
- Conducted more than 10 international CTs.
Experienced in all steps of clinical study organisation and performing, as a monitor, study co-ordinator, clinical project manager, Head of the group:
- Feasibility completion; Study budget planning and management
- Pre-study activities: site selection and evaluation, creation of submission letters to Regulatory Authorities and IEC, approvals obtaining, study files management, study team creation and management, start-up meetings organisation. Recruitment control, sites and CRAs motivation.
- Monitoring activities – study control and oversight, MVR review, CRAs’ team meetings, CRA’s training and development in therapy area, co-visits to investigational sites
- Study metrics analysis, control on study team performance, communication of study status to study team, risk identification and management, CAPA performance in case of issues.
- International databases and IV/WR systems – local expert. Experienced in e-DC studies
- Post study activities: site closure, archiving; Study logistics – courier service, logistics documents.
- Local studies – protocols and procedure expertise.
OTHER RELEVANT EXPERIENCE:
TRAINING:
· study specific training for all conducted studies,
· Company SOP and systems training – 2001 – 2021 yy, regularly
· Training on company’s databases, Safety, auditing.
· Presentation skills
· Leadership essentials
· Participation in AIPM working group “Quality of Clinical Trials”, presentation at Oncology Conference “White Nights” Jun 2020 (Audits and audits behavior), presentation in frame of AIPM educational project for students of Moscow Medical University – Apr 2021 (International and local legislation in clinical trials).
Personal information
Responsible, time and goal – oriented (work must be done), supportive to people, communicative, hard worker, work well individually or in a team, able to travel, have good presentation and organization skills, good analytical skills, opened to changes and new knowledge, fast learner and ambassador for new processes and systems, effective work with big volume of information
Additional information
Driving license, foreign passport.
Hobby - Table tennis