Beata Maciejewska

Therapeutic Area Experience: Oncology and Hematology, Central Nervous System, Cardiovascular, Respiratory: asthma and COPD, Vaccines: therapeutic vaccines and prophylactic vaccines, Immunology, Gastroenterology, Observational studies

• The overall efficient day-to-day management of the trials
• Line management responsibilities for staff members
• Recruitment, retention, training, appraisal and supervision of trial team members
• Establishment of procedures to ensure adherence to trial protocols and administrative requirements
• Monitoring the trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify problems
• Management of the trial budgets and maintenance of the accounts
• Serving as primary interface between company and sponsors, vendors and other departments in the area of full service project management
• Assisting in and developing of Standard Operating Procedures (SOPs), data management tools, training, budgets, and staffing requirements
• Regularly reviewing all relevant projects for quality
• Interacting with regulatory authorities

Therapeutic Area Experience: Pulmonology – 4 studies, Neurology – 3 studies, Cardiology – 2 studies, Vaccination – 2 studies
• Coordination of trials on the country level according to the quality standards, timelines and budgets
• Assessing performance of CRAs - trainings, mentoring, performing co-monitoring visits in sites, verifying monitoring visits reports
• Coordination of Local Investigators Meeting in Poland
• Taking part in process of employment new CRAs
• Chairperson during teleconferences and monthly meeting of CRAs
• Preparation of CRAs and Sites for audits, participation in audits
• Creation and maintenance of all trial files, including the trial master file

Therapeutic Area Experience: Oncology, Cardiology, Pulmonology, Neurology

• Feasibility, Pre-Study, Initiation, Monitoring and Close-out Visits
• Properly maintaining the Trial Master File to be audited at any time
• Preparing the documentation and material needed for the start-up visits of the clinical trial
• Collaborating in the organisation of the investigator meetings
• Ensuring and guaranteeing the quality of data that the investigator collects
• Detecting any problems during of the performance of the clinical trial (protocol deviations, delayed timelines, suspicion of fraud, etc.) and propose solutions
• Overviewing/managing the operations related to study treatment/rescue medication and clinical samples at the site
• Participation in Sponsor’s audits

Therapeutic Area Experience: Diabetes, Cardiology, Pulmonology

• Feasibility, Pre-Study, Initiation, Monitoring and Close-out Visits
• Properly maintaining the Trial Master File to be audited at any time
• Preparing the documentation and material needed for the start-up visits of the clinical trial
• Collaborating in the organisation of the investigator meetings
• Ensuring and guaranteeing the quality of data that the investigator collects
• Detecting any problems during of the performance of the clinical trial (protocol deviations, delayed timelines, suspicion of fraud, etc.) and propose solutions
• Overviewing/managing the operations related to study treatment/rescue medication and clinical samples at the site
• Participation in Sponsor’s audits