Kateryna Oliinyk

Compliance with regulatory and company standards, manage QA control, CRO oversight and quality governance, ClinOps and TMF processes. GCP & GMP environments, vendor oversight, and quality systems management. Key Responsibilities: - Lead QA oversight for CROs and external service providers. - Establish governance frameworks and monitor quality metrics. - Coordinate audits, inspections, and ensure compliance. - Manage QA process control and TMF quality monitoring. - Drive continuous improvement and regulat

TMF and GxP archiving business owner and TMF team manager. Leading several projects and teams in Quality focused way. Have a deep knowledge on Clinical Operations and Development activities as a part of Development leadership.

My function includes but not limited to GLPG TMF Owner, Veeva System Business Owner, TMF Specialists team lead. Responsibilities: =>Veeva Access, Risks, System & Process Issue Management =>Archiving & Template management =>Oversight of study TMFs on company level =>Audits support =>TMF Imports and Exports =>Procedural documents creation, maintenance & updates =>CAPA management, strategic change management => Functional Area awareness trainings creation & presentation. + Technically oriented support of my

Assist CRAs with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Collaborate with CRAs on the preparation, handling, distribution, filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness. Act as central contact for the clinical team for designated project communications, correspondence and assoc

Responsible for the completeness and quality of the in-house site specific files • Track system access of PAREXEL team members • Update all relevant tracking system on an ongoing basis Maintain team list and sponsor / vendor details Act as the in-house site support, receive inbound calls and address issues based on experience either directly or inform appropriate team member Collect regulatory documents in collaboration with CRA and CTS as needed Conduct outbound calls to review: recruitment plan and enroll

Project and Team coordinating, as a responsible for several(up to 7) projects at one time managing multiple tasks, problem solving, business communication and negotiation with Clinical sites (Hospitals, Universities, Pharmaceutical companies, Clinical laboratories and other partners). Regulatory submissions & notifications (Initial, Annual, Amendments, SUSARs, Insurance etc.). Performing co-monitoring visits at sites Close-outs. Responsible for IP Regulatory submissions/ notifications for 2 IP. Control, fi