Yana Globina
Clinical Transparency Manager
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Sobre mí
Specialist with almost 12 years of experience in Trial Transparency responsible for managing and supervising operational production of disclosure deliverables for studies in large, complex therapeutic areas, including but not limited to early phase development and vaccines. Accustomed to working closely with cross-functional teams from multiple regions and countries, requiring a strong communication component. Valuable participant in key initiatives related to the changing regulatory landscape and transversal collaborations on public disclosure.
Pharmacist by background with an additional master’s degree in Monitorization of Clinical Trials and postgraduate in Regulatory Affairs of pharmaceutical and related products.
Experiencia
April.2021 – Present SANOFI Senior Trial Transparency Manager
- Cross-functional collaboration to assess disclosure applicability in EU, UK, US, ROW and company commitments for assigned portfolio. Specialized in early phase oncology, 1-4 phase rare diseases, neurology, respiratory and vaccine clinical trials.
- Management and submission of study protocol registration, scientific results, and lay summaries on global and local portals
- Development of clinical disclosure strategies for sensitive products to ensure compliance with regulation and company interests.
- Lead meetings to train team on redaction and lay summary processes.
- Provide guidance on best practices to ensure quality of information shared publicly.
- Manage and oversight vendors activities on preparation of results, ensuring timely production of high-quality deliverables.
- Develop and lead training and other communication efforts aimed at a variety of audiences, to enhance audience understanding of various aspects of the disclosure field.
- Protocol registrations and updates on ClinicalTrials.gov, EudraCT and EUPAS Registry (Neuroscience, Oncology, Rare diseases) phase 1-4 clinical trials
- Coordinate medical information inquiries regarding ongoing and completed clinical trial
- Oversight of posting of clinical trial information on local portals to ensure consistency.
- Performed review of SOPs, company internal policies and work instructions according to current EU and US clinical data transparency and disclosure regulation
- Govern cross functional preparatory meetings and benchmarking for Transparency Board
- Monitored updates and prepared trainings about EU CTR and CTIS
- Responsible for maintenance and QC of eTMF disclosure documents
- Responsible for regulatory life-cycle of 15 pharma products in the Middle-East, LATAM, Africa, and Asia.
- Managed new CTA and amendments to AEMPS and CEIMs (VHP, low interventional use, advanced therapy)
- Managed protocol and results preparation for ReeC, ClinicalTrials.gov, EudraCT
- Redacted clinical trial documents for EMAs Policy 0070
- Project lead in preparation of new registration dossier, renewals, and variations for 30 drugs for 5 pharmaceutical companies. Submissions in CIS countries, Asia and anglophone Africa
- QC check of new dossiers for completeness and compliance with current local regulation. Guide preparation of responses to regulatory queries.
- Development of Module 2, 4 and 5 of CTD dossier for ROW.
- CMC expert for Reg Affairs to prepare submission strategy.
- QC check of labeling material (labels, leaflets, SmPCs) and translations of texts (accuracy and completeness)
- Proactively updated manufacturer about changes in local legislation and guidelines.
- Assessed budget plans and present costs to forecast trends and recommend changes. Produced monthly data analysis tables and results reports outlining financial data to assist management with making strategic plans and operational decisions.
- Met quarterly goals by proactively managing individual and team tasks and implementing new corporate processes.
- Prepared and run monthly campaigns in cooperation with marketing team
- Recruited, interviewed and coached trainees to promote positive feedback and engagement. Assessed employee performance and developed improvement plans. Led team of 8 staff.
- Worked with broad range customers to understand needs and provide excellent service
- Prepared monthly sales data reports for headquarters. Prepared weekly sales reports to assist branch manager with monthly sales strategy. Weekly reporting of sales figures (member of sales team)
- Coached recently graduated students to create professional attitude and motivate to better understand pharmacy client’s specificity. Carried out ongoing trainings for colleagues about innovations in diabetes area.
- Realized narcotics control and prepared daily doses for methadone clients.
- Actively participated in organization of company's leisure activities and events
Educación
2023 - PMI Project Management Ready
Certification of Project Management Institute
2012 - 2013 Postgraduate: Reg Affairs of Pharmaceutical and Related Products
University of Barcelona (UB)
2011 – 2012 Master of Science: Monitorization of Clinical Trials
Official Medical College of Barcelona (COMB) – Barcelona
2005 – 2006 Title Homologation and Diploma Convalidation: Pharmacy
Høyskolen i Oslo, Norway
1997 - 2002 Master of Science: Pharmacy
SPb State Chemical and Pharmaceutical Academy - St. Petersburg
