Clinical Trial Manager Performing Services for Amgen Dec 2022 – Sep 2024

Performs the role of Local Trial Manager (LTM) including operational oversight of assigned protocols from start-up through to database lock and closeout activities as described in GCO procedural documents. LTM is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries.

The LTM is the primary point of contact at a country level for assigned studies.
 Countries handled (No. of sites): Russia (15)
 Study Stages handled: Maintenance; Close-out.
 Study phase: II-III

Performs the role of Local Trial Manager (LTM) including operational oversight of assigned protocols from start-up through to database lock and closeout activities as described in GCO procedural documents. LTM is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries.

The LTM is the primary point of contact at a country level for assigned studies.
 Countries handled (No. of sites): Russia (19) Belarus (4)
 Study Stages handled: Maintenance; Close-out.
 Study phase: II-III

Clinical Operations Manager Performing Services for MSD Oct 2019 to Dec 2020

Job Description Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities included: Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA) Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles Executes and oversees clinical trial country submissions and approvals for assigned protocols Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country Contributes to the development of local SOPs. Oversees CTCs as applicable Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones Collaborates closely with Headquarter to align country timelines for assigned protocols Provides support and oversight to local vendors as applicable Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and CV_Veronika_Shifrova_22042025 Page 4 of 5 retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems Ownership of local regulatory and financial compliance.

The position has a significant impact on how a country can deliver countryspecific trial commitments and objectives especially during study start-up Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions.

Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value Responsibilities:
 Countries handled (No. of sites): Russia (56)
 Study Stages: Validation, Start-up; Ongoing; Close-out
 Study phase: II-III

Clinical Research Associate II Performing Services for MSD Oct 2018 to Oct 2019

Job Description Conducted validation, initiation, monitoring, and close-out visits according to SOPs and GCP. Responsible for overall site management for assigned sites including written and verbal communication and scheduling of monitoring visits. Responsible for completion of visit reports and maintenance of study-related databases.

Mentoring for new employees. Responsibilities:
 Countries handled (No. of sites): Russia (12)
 Study Stages handled: Validation; Start-up; Maintenance; Close-out
 Study phase: II-III

CRA-SCRA Sep 2014 to Oct 2018

Job Description Conducted validation, initiation, monitoring, and close-out visits according to SOPs and GCP. Responsible for overall site management for assigned sites including written and verbal communication and scheduling of monitoring visits. Responsible for completion of visit reports and maintenance of study-related databases. Responsible for regulatory submission, mentoring for new employees, co-monitoring, feasibility questionnaire development.

Responsibilities:
 Countries handled (No. of sites): Russia (21)
 Study Stages: Feasibility; Start-up; Ongoing; Close-out
 Study phase: II-IV

Project Assistant Apr 2010 to Sep 2014

Job Description Project Assistant provides the administrative support to the clinical research teams in the full spectrum of the research activities such as pre-study, study start up, site management and site closure. Assists in gather and the preparation of documents for clinical trial applications for the submission and approval from the competent authority and ethical committees. Responsible for the correct filing and archiving of clinical trial documents, and the maintenance of study files. Provides support in meeting activities such as organizing and planning of meetings (e.g. investigator-, project-, team meetings), and provide meeting minutes.

Responsibilities:
 Countries handled (No. of sites): Russia (20)
 Study Stages: Feasibility; Start-up; Ongoing; Close-out
 Study phase: II-IV

Clinical Site Manager Jun 2009 to Feb 2010

Job Description Clinical Site Manager provides the administrative support to the clinical research teams in the assigned clinical sites Responsibilities:

 Countries handled (No. of sites): Russia (2)
 Study Stages: Ongoing
 Study phase: III

Intensive care nurse Aug 2007- Aug 2012

Job Description The Intensive Care Unit Nurse is a highly skilled and specialized healthcare professional responsible for providing critical care to patients with severe and life-threatening medical conditions. They work in the intensive care unit, monitoring patients closely and delivering specialized treatments to stabilize and improve their health outcomes.