Trial Lead of start up of Clinical trials at HQ from Protocol outline to final recruitment.

Clinical Project Leader responsible for the pivotal trial of Hansas pipeline within kidneyTx. Line manager for +10 staff within Clinical Operations, including resource planning, performance management talks and daily activities as 1:1s.

Project Manager for large global studies and my daily work was to pro-actively manage multidisciplinary study teams (including Site Management, Data Management, Statistics, Medical Writing, Regulatory and Safety including medical monitoring) to ensure key milestones are achieved and studies are performed within budget, on schedule and in compliance with the appropriate - and quality standards.

Responsible Lead CRA in several studies.Lead CRA tasks: - Manage site selection, site initiation, site monitoring and site close-out- Manage clinical trial supplies against the defined project-specific quality and performance standards (i.e. project requirements, relevant SOPs, ICH/GCP and local requirements). - Implementation of monitoring/recruitment plans and design of CRF completion guidelines. - Review of laboratory manual- Manage of study related meetings- Assist in the preparation of the draft study protocol, draft CRFs and template of informed consent- Preparation of site manuals, pharmacy/investigational medicinal product manual, source documents and other documents required for the conduct of the clinical trial- Provide support and guidance to CRAs- Review of site visit reports (PSV, SIV, MV and COV)- Update to the Project leader with the status from sites and any problems from the CRA team- Ensure documents remain current during the course of the trial and ensure maintenance of trial master file

To ensure study timelines and budgets are kept and that studies proceed according to agreed plans at site, country and or Nordic level. To plan, organise, initiate, monitor, close & report clinical trials in the Nordic countries in compliance with ICH/GCP guidelines, the Clinical Trial Directive, local laws, guidelines and SOPs. Responsible for Country feasibility.Coordinate and manage communication between study management and the Nordic study team. Identify and recruit investigators in cooperation with product and country managers. Perform and report site feasibility.Produce CA and EC documents in cooperation with study management. Submit CA and EC applications in the Nordic countries. Estimate study budget.Negotiate clinical trial agreements.Coordinate, traine and support Nordic study team.Review and approve monitoring visit reports.Perform quality control checks of study conduct and documentation. Order, organise, produce study materials and documents and organise archiving. Plan, organise, and present study information at Nordic investigator meetings. Participate in international investigator and monitor meetings. Liaise with and train investigators and other study personnel. Ensure that the conduct of the study is thoroughly documented. Report study progress continuously in clinical trial management system. Escalate quality, timeline, budget issues to study management. Organise and approve study related payments. Monitor expenditure against study budget and update budget periodically.Initiate, monitor and close study sites.Handle investigational medicinal product.Attended an Astellas customized project management course for a total of about 6 working days. Topics:- Communication- Reporting- Feedback- Management of a project- Risk management- MS project

I have been working with clinical trials during 4 years and I have gained a lot of experience by working with different indications and phases of the clinical trials. I have made a lot of submissions to the Ethics committees, negotiated contracts with both the clinics and the pharmacies. I have set up biobank agreement and done both pre-study visits, initation visits, monitoring visits and close out visits. Site management has of course been a daily part of my job. I have also done monitoring in UK. I have also had the responsibilities of reviewing monitoring reports of other monitors in the study team and setting up monitoring manual. I have also been involved in the study protocol writing process.

I was working at the Regulatory Affairs Department where we were working close as a team, solving and discussing the issues regarding the broad area of Regulatory Affairs. I got great experience in marketing authorization registrations, clinical trials registrations, FASS, labeling, summary of product characteristics, patient leaflet information, translations and also participation in tasks related to internal regulatory support within TFS.