🔷 I was extended the opportunity to join the Institute of Hematology and Transfusiology in Warsaw as the Head of the Oncology Clinical Research Support Center. In this capacity, I collaborate with a cross-functional team of scientists and medical professionals from various specialties to co-develop and advance innovative clinical projects, aimed at providing patients with new therapeutic alternatives. It is a privilege and a distinct honor to work alongside such distinguished experts, an… Show more 🔷 I was extended the opportunity to join the Institute of Hematology and Transfusiology in Warsaw as the Head of the Oncology Clinical Research Support Center. In this capacity, I collaborate with a cross-functional team of scientists and medical professionals from various specialties to co-develop and advance innovative clinical projects, aimed at providing patients with new therapeutic alternatives. It is a privilege and a distinct honor to work alongside such distinguished experts, an experience that brings unparalleled professional fulfillment.🔷 My principal responsibilities:▪️ Supervision of clinical trials at the Institute.▪️ Collaboration with sponsors, contract research organizations (CROs), vendors, the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, research teams, principal investigators, and the Bioethics Committee.▪️ Oversight of the research teams in the conduct of clinical trials within institutional settings, with particular emphasis on managing relationships with sponsors of commercial trials and funders of non-commercial research.▪️ Governance over the coordination of clinical trial contracting, ensuring rigorous substantive, legal, and financial assessments, and overseeing negotiations on contract terms.▪️ Conduction of continuous performance analyses of the Oncology Clinical Research Support Center at IHiT, to ensure alignment with strategic development plans, and preparing comprehensive plans and reports on the Center’s research activities.▪️ Collaboration with the Medical Research Agency to submit proposals for new non-commercial clinical trial projects.▪️ Proactively seeking opportunities to secure new clinical trials, working closely with CROs and sponsors, and promoting the Center both nationally and internationally. Show less

🔷 Conducting practical classes and seminars for students in the clinic.

🔷 Conducting practical classes and seminars for students in the hospital department.

🔷 Being a member of JJP Biologics' clinical team, I became part of the innovative biotechnology company developing the next generation of novel biologics in the field of personalized medicine. It was a pleasure to be part of such a professional and motivated team, creating new therapeutic options for patients worldwide.🔷 My responsibilities included:▪️ Providing scientific leadership and guidance for research and development projects.▪️ Contributing to the design and execution… Show more 🔷 Being a member of JJP Biologics' clinical team, I became part of the innovative biotechnology company developing the next generation of novel biologics in the field of personalized medicine. It was a pleasure to be part of such a professional and motivated team, creating new therapeutic options for patients worldwide.🔷 My responsibilities included:▪️ Providing scientific leadership and guidance for research and development projects.▪️ Contributing to the design and execution of experiments and studies.▪️ Developing and implementing clinical trial protocols in accordance with regulatory requirements.▪️ Managing clinical trial operations, including site selection, monitoring, and data collection.▪️ Ensuring compliance with Good Clinical Practice (GCP) guidelines and other regulatory standards.▪️ Collaborating with clinical investigators, CROs, and other stakeholders to drive clinical trial success.▪️ Supporting the preparation of regulatory submissions and documentation, including Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs).▪️ Supporting regulatory interactions and audits as needed.▪️ Developing project plans and timelines, ensuring alignment with organisational goals.▪️ Monitoring project progress and identifying potential risks or obstacles.▪️ Implementing strategies to address challenges and optimising project outcomes. Show less

🔷 While working at an early-phase center, I co-created research protocols and key research documentation, and developed a strategy and schedule for international early-phase clinical trials. I supervised the research team at the clinical center, worked directly with vendors, participated in audits, and led strategic meetings as a center representative. I handled tools such as the Airtable, Hyggio, and Kanban tables.🔷 This diversity of perspectives allowed me to look at clinical trials… Show more 🔷 While working at an early-phase center, I co-created research protocols and key research documentation, and developed a strategy and schedule for international early-phase clinical trials. I supervised the research team at the clinical center, worked directly with vendors, participated in audits, and led strategic meetings as a center representative. I handled tools such as the Airtable, Hyggio, and Kanban tables.🔷 This diversity of perspectives allowed me to look at clinical trials from different angles, which definitely increases the attractiveness of this area of medicine. In my daily work, I particularly valued working in multidisciplinary research teams, both at the national and international levels.🔷 In addition, I also gained positive energy from valuable relationships with friendly and competent people whom I had the pleasure of meeting on my professional path; this gave me constant positive energy. Direct contact with patients was also extremely important to me.🔷 Key responsibilities:▪️ Comprehensive management of global clinical trials (phase I-IV),▪️ Managing a multidisciplinary research team,▪️ Project risk forecasting and management,▪️ Preparation of relevant documents for the conduct of a clinical trial e.g. schedules, protocols, consents, instructions, plans, etc,▪️ Tracking milestones and monitoring the recruitment rate,▪️ Cooperation with functional teams e.g. the recruitment department and patient engagement,▪️ Conducting investigator meetings, kick-offs, trainings, and status meetings,▪️ Supervision of all vendors on the project,▪️ Representation of the site and direct communication with stakeholders,▪️ Assistance with IMP dosing,▪️ Participation in audits and inspections. Show less

🔷 As a Clinical Research Associate, I was responsible for comprehensive monitoring of the progress and quality of phase clinical trials and the selection of clinical sites. Simultaneously, I played the role of Associate Clinical Trial Expert, co-creating key research documentation, estimating project risks, and negotiating contracts with researchers, sites, and laboratories, while supervising the work of the CRO (Contract Research Organisation) on behalf of the sponsor. I handled tools such as… Show more 🔷 As a Clinical Research Associate, I was responsible for comprehensive monitoring of the progress and quality of phase clinical trials and the selection of clinical sites. Simultaneously, I played the role of Associate Clinical Trial Expert, co-creating key research documentation, estimating project risks, and negotiating contracts with researchers, sites, and laboratories, while supervising the work of the CRO (Contract Research Organisation) on behalf of the sponsor. I handled tools such as the MS Project and Power BI.🔷 My detailed scope of responsibilities included: ▪️ Contributing to the preparation of the documents necessary for the conducting of clinical trials in accordance with the requirements of ICH-GCP, ▪️ Writing RFP and tender applications, ▪️ Comprehensive site management activities to ensure timely delivery of enrollment readiness and trial recruitment, ▪️ Supervising key project milestones, ▪️ Ensuring adequate and effective communication with the project team, vendors, external experts and other functional groups,▪️ Verifying documents related to the study e.g. Project Management Plans, Safety Management Plans, Medical Monitoring Plans, IMP Management Plans, ▪️ Risk identification and implementation of corrective actions, ▪️ Participating in audits, ▪️ Updating SOPs and process mapping in the Clinical Trial Department. Show less

🔷 Key Responsibilities: ▪️ Creating trial protocols, and presenting these to the steering committee,▪️ Identifying, and establishing trial sites, and closing sites down on completion of the trial, ▪️ Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion, ▪️ Liaising with the ethics committee regarding the rights, safety, and well-being of trial subjects, ▪️ Ordering, tracking, and managing IP and… Show more 🔷 Key Responsibilities: ▪️ Creating trial protocols, and presenting these to the steering committee,▪️ Identifying, and establishing trial sites, and closing sites down on completion of the trial, ▪️ Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion, ▪️ Liaising with the ethics committee regarding the rights, safety, and well-being of trial subjects, ▪️ Ordering, tracking, and managing IP and trial materials, ▪️ Overseeing and documenting IP dispensing inventory and reconciliation, ▪️ Protecting subjects' confidentiality, updating their information, and verifying if IP has been dispensed and administered according to protocol, ▪️ Conducting regular site visits, coordinating project meetings, and writing visit reports, ▪️ Implementing action plans for sites not meeting expectations. Liaising with regulatory authorities, ▪️ Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines,▪️ Side tasks and responsibilities, such as negotiating agreements with investigators or vendors, and performing feasibility studies at new sites. Show less

🔷 Cooperation with teams of medical experts.