Elżbieta Saja

-Responsibility and oversight of local clinical trials activities according to the protocol, GCP, country specific requirements and MSD policies and standards to keep the highest quality and attach committed timelines,
• Responsibility for country budget in the range of contract negotiations with the sites, oversight and tracking of clinical related payments for investigators and institutions, maintenance of external MSD financial systems (gPPC),
• Country submissions and local language, country specific documents preparation required by HA and IRB. Keeping informed Regional Regulatory Department about local submission via Orion system,
• Keeping control over study related timelines and deadlines in assigned protocols. Reporting to RCPM, CRM, SrCOM study status and progress in the trial. Tracking and regular updating all study specific deliverables in Spectrum,
• Cooperation with CRM, CTC, CRA, Finance and Legal Department to ensure country commitments for submission, budgets, financial agreements are met. Collaboration with Regional Operations and supplies vendors to ensure smoothly study initiation and site readiness.
• Control over local processes in the range of clinical and ancillary supplies managements, supplies destruction, documents archiving in paper and electronic version.
• Local SOPs development,
• Contribution to study-level risk assessments. Risk Management

-Supervision all aspects of project management activities (2 trials: in oncology and psychiatry, with 3 countries each, 15 CRAs, 4 CTAs as total)
• Overseeing the planning and development and implementation of assigned clinical trials,
• Supervision realization of planned study recruitment at all stages (recruitment completion in compliance with assumptions)
• Supervision budget of the assigned clinical trials: prepares and verifies offer budget, supervises budget during realization stage, monitors pass through costs and CRO remuneration,
• Contribution to study-level risk assessments. CAPA implementation. Preventive actions preparation and CRAs’ training,
• Cooperation with sponsor in the scope of trial registration in local Competent Authorities (2 study submissions performed ahead of schedule)
• Ensuring implementation of studies in accordance with SOPs, ICH/GCP guidelines and local law regulations.

As Local Trial Manager - managing many aspects of international trials conducted in Poland (Hematology IIb, Psychiatry III. Nephrology IV, Rheumatology III ph, Cardiology III, Diabatology III , Oncology III),
• Identifying and resolving issues at a regional level,
• Leading and review regional risk mitigation activities to ensure study delivery to plan,
• Overseeing study recruitment level (exceeding commitment by 20% in several trials),
• Supervision approximately 10 CRAs and 4 CTAs within the studies,
• Reviewing and approval monitoring visit reports,
• Perform quality checks over submission documents and site essential documents,
• Budget planning for the trials, budget control during the study,