Natalya Antoshenkova

Projects

• Regional lead covering EMEA region on a full start up project (within EU CTR) in the therapeutic area of oncology.
• Global lead on a maintenance fragile X syndrome study within USA/UK/EMEA regions + Australia.
• Global lead on a maintenance fragile X syndrome study within USA/UK/EMEA regions + Australia
• Regional lead on a maintenance ophthalmology study across 13 countries within EMEA.
• Regional lead on a maintenance ophthalmology study across 14 countries within EMEA.

Functional Responsibilities

• Successfully managed multiple projects within tight deadlines simultaneously by coordinating team efforts, prioritizing tasks effectively according to urgency, resource availability, and alignment with organizational goals.
• Minimized project risks by actively identifying, evaluating, and implementing strategies for their mitigation.
• Provided oversight and assumed full accountability for all project start-up deliverables which incorporate all activities from site selection through site activation readiness and into the life cycle maintenance of projects.
• Cultivated strong relationships with clients through regular communication and transparent reporting on project status updates, fostering trust and long-term partnerships.
• Enhanced project delivery timelines by streamlining communication channels between major functional areas including, but not limited to: Business Development, Contracts and SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.
• Coordinated country SSU Associates, maintaining a positive work environment throughout the project lifecycle.
• Developed and managed site start-up timelines and reported on a weekly basis progress including plans to address potential timing risks/gaps.
• Prepared the core submission documents and core clinical trial application dossiers
• Was in charge of collation, quality review, and submission of country-specific applications.
• Assisted in initial or amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department.
• Supervised the negotiation and execution of clinical trial agreements and budgets within established deadlines.
• Reviewed the project SSU budget with Project Manager against project milestones and budget to ensure project profitability. Implemented necessary corrective actions to ensure projects remain within budget constraints.
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Projects

• Global lead covering 7 countries across EMEA on a full start up project.
• Regional lead on a maintenance paediatric study across 7 countries across EMEA and APAC regions.
• Overseeing and project managing the study start up activities and country SSU teams for clinical trials across EMEA and APAC regions.

Functional Responsibilities

• Overseeing and project managing the study start up activities and country SSU teams for clinical trials across EMEA and APAC regions.
• Full accountability for all project start-up deliverables which incorporate all activities from site selection through site activation readiness and into the life cycle maintenance of projects.
• Enhanced customer satisfaction by consistently meeting or exceeding project delivery milestones and quality standards.
• Prepared and presented overall SSU strategy and status at client meetings and provision of outcomes to project team.

• Leading projects with regard to customs activities managing; start-up of the study.
• Vendor management for customs clearance, distribution among the sites and purchase of study drugs and materials.
  Vendor Management for export activities (including study devices and biological samples).
• Active participation in new business development activities including participation at client presentations. Providing information to support business development activities.
• Vendor selection, contract negotiation and execution.
• Identification of potential issues. Seeking guidance to resolve more complex and routine issues.
• Continuous improvement of import/export process.
• Tracking all study specific activities; planning the activities; control the budget / targeted timelines compliance.
• Timely and effective communication among team members, finance team, broker, third party depot, central laboratories, clinical team, and sponsor.
• Dossiers preparation for import/export licenses applications.

• Leading projects with regard customs activities managing; start-up of the study.
• Preparing, compiling, submitting relevant docs for trials authorization receiving.
• Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with the company's SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan, Russian Federal law regulations.
• Review and approval of regulatory & investigator documents for study site activation and drug shipment trigger.
• Review of core Country patient informed consents and patient materials for compliance to country requirements and protocol as applicable.
• Liaise with applicable IRB/IEC regarding investigator submission/approval issues as appropriate.
• Setup and maintain regulatory section of TMF.

• Managed vendor activities for customs clearance and distribution
• Liaised with project management and prepared documents for regulatory submissions.

• Liaised with study sites and maintained relationships with investigators
• Coordinated activities with CRA and provided study information to sponsors.

• Liaised with study sites and maintained relationships with investigators
• Coordinated activities with CRA and provided study information to sponsors.

• Managed vendor activities for customs clearance and prepared documents for regulatory submissions.

• Prepared and maintained study files and assisted with regulatory submissions and approvals.

• Provided administrative support to the department and assisted with teaching.