Edyta Dąbrowska

• Responsible for the supervision of assigned direct reports.
• Responsible for detailed performance review and management of a f assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and "Shoves & Tugs".
• Effectively communicate management strategies, policies and procedures in conjunction with leadership teams .
• Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment.
• Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.
• Has regulatory oversight of direct reports by ensuring regulatory training is executed, understood and implemented.
• Perform weekly review of direct report billable hours and utilization (in context of project allocation, supply and demand); escalate of outliers and assists management team for mitigation.
• Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports.
• Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity.
• Identify, develop, and implement measures to improve the efficiency of the department.

• Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally
• POC for assigned protocols
• Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols
• Strong collaboration with local CO roles
• Forecasts country resource needs
• Serves local business needs (signs contracts, manages budgets as delegated)
• Responsible for quality and compliance in assigned protocols in country
• Oversees CRAs and CTCs on assigned projects
• Oversees training compliance
• Performs quality control visits
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed
• Oversees associate CRMs assigned to the Client and work on training needs in collaboration with functional vendor
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners
• Oversees country and site validations, site selection and recruitment in assigned protocols
• Responsible for clinical trial education to sites
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.

• Led Local Study Team at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations
• Responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

• Worked on the operational delivery of clinical study, via a team of contributing experts ensuring adherence to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP
• Ensured the work is consistent, and shared best practices when working across studies or project work package
• Contributed to the development of study project plan, study communication plan, global monitoring plan, data cleaning strategy
• Contributed to the development and review of study documents
• Oversaw the study performance on global and participating countries level through regular monitoring of defined metrics and KPIs and escalated the issues in accordance with an escalation plan
• Contributed to study and patient recruitment strategy
• Identified, monitored, ensured documentation of risks when it comes to country performance and supported risk mitigation
• Planned and led global Calls with countries
• Contributed to the planning and conduct of internal and external meetings (e.g
• Investigators'/Monitors' meeting and trainings)
• Acted as a first point of contact toward Site Management and Monitoring (SMM) ensuring effective collaboration and study delivery to time, cost and quality
• Contributed to maintenance of realistic, up to date and appropriate quality, project and study plans (KPI).

• Provided leadership of group work and building the team spirit
• Contributed in resources assignment for studies
• Contributed to high quality feasibility work
• Contributed to the quality improvement of the study processes and other procedures
• Planned and organized coaching of the team members
• Contributed in hiring of new contracted CRAs and onboarding
• Contributed in overall CRAs performance evaluation and goals assignment
• Performed co-monitoring visits.

• Had overall responsibility for the study commitments within the country, for timely delivery of data to required quality
• Led and optimized the performance of the multi-disciplinary MC Study Delivery team ensuring compliance with AZ Procedural Documents, ICH/GCP and local regulations and updated other study team members on study materials
• Proactively identified and facilitated resolution of complex study problems and issues
• Was a member of Study delivery team and participated in Study Delivery Team meetings
• Actively worked towards achieving good personal relationships with the Study Delivery Team members
• Contributed to patient recruitment strategy
• Coordinated the process for the selection of potential Investigators
• Planned and led Investigator meetings
• Assisted in forecasting study timelines, resources, recruitment, budget, study materials and drugs
• Worked together with Regulatory Affairs to ensure timely delivery to proper application/documents for submissions to Regulatory Authority
• Ensured accurate payments related to the study are performed
• Participated in training and mentoring of new members of the MC study Delivery team ensuring compliance with ICH/GCP and AZ Procedural Documents
• Planned and led activities associated with audits and regulatory inspections in liaison with CQA
• Provided input to process development and improvement
• Trained, supported and advised Investigators in study related matters.

• Performed full monitor's activities, including feasibilities, attendance to Investigator Meeting, delivery GCP training's, delivery study specific trainings, submissions to Regulatory body and Ethics Committees, Site Selection Visits, Initiation Visits, Monitoring visits & SDV, Closure visits, query resolutions, drug accountability, AEs and SAEs management, reporting non-compliance and deviations from study protocol requirements, audits, accompanied visits with Sponsors and internal Quality Managers
• Worked as a LEAD CRA in large multinational studies phase IIa, IIb and III
• Accompanied CRAs during their visits at site.

• Performed full monitor's activities (as mentioned above).

• Assisted CTL and CRAs with currently updating and maintaining clinical systems that track site compliance and performance within project timelines
• Assisted the clinical team in preparation, handling, distribution, filling and archiving of clinical documentation and reports according to the scope of work and SOPs
• Assisted with periodic review of study files for accuracy and completeness
• Assisted with the tracing and management of Case Report Form, queries and clinical data flow
• Acted as a central conduct for the clinical team for designed project communications, correspondence and associated documentation.

• Planned and organized work with 25 trials, phase II - III according to the ICH GCP and hospital requirements
• Prepared and submitted documentation to Ethics Committee
• Supported investigators in filling CRFs and eCRFs, answering queries
• Reported AE and SAE
• Worked with IVRS systems
• Worked with central laboratories.