Reka Rusz Burman Email & Phone Number

Copenhagen, Capital Region, Denmark

Copenhagen, Capital Region, Denmark

Copenhagen, Capital Region, Denmark

København, Capital Region, Denmark

Lund, Sweden

As Senior Start Up Lead, main responsibilities containing leading all aspects of Clinical Start-up activities on country/region or project level to achieve successful activation of sites within timeline and according to budget while assuring that all tasks meet Client and PRA expectations and are delivered in accordance with, the contract, trial protocol, ICH-GCP, applicable local regulations and -requirements, and SOPs. Other responsibilities as Senior Start Up lead is mentoring junior colleagues settling in their new role as Start Up Leads and support them with identifying risks and mitigate these on a high level as well in detail if required. I find the mentoring task challenging but at the same time extremely awarding, allowing me to develop on a personal- as well as on a professional level by learning new things about myself as well as about how to best support my colleagues in their development.

Lund, Sweden

As Start Up Lead, I managed and lead all aspects of Clinical Start-up activities at the country/region and project level to achieve successful activation of sites within timeline and according to budget.Responsible for ensuring that all tasks meet Client and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable local regulations and requirements, and SOPs. Managed successfully a major clinical program as Global Start-Up Lead under its start up cycle, containing 3 parental protocols and 1 long term extension study. Main responsibilities were discussing and setting-up study start up strategies internally within PRA and in collaboration with client, reporting study start up progress, -risks and mitigation plans both internally and directly to the client, providing support to the regional Start-Up Leads in the program achieving great success by early closure of patient enrollment in all 3 parent protocols.

Scandinavia

Responsible for start-up of clinical trials in Scandinavia. This includes: recruiting sites, ethics committee submissions, essential document review, investigator contracts, study and site status tracking, etcEnsures that all tasks meet client and PAREXEL expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP, local legislation and applicable Standard Operating Procedures (SOPs).

Lund, Sweden

As Start Up Lead, I managed and lead all aspects of Clinical Start-up activities at the country/region and project level to achieve successful activation of sites within timeline and according to budget.Responsibility for ensuring that all tasks meet Client and PRA expectations and are delivered in accordance with the contract, trial protocol, ICH-GCP, applicable local regulations and requirements, and SOPs.

Responsible for implementing consistently the Start-up Methodology. Participating in design & development of regional patient ICF and other protocol specific documents in accordance with applicable regulation/requirements. Overseeing Clinical Operations staff dedicated to country start-up activities on a project. Ensure that essential documents are developed, collected, reviewed & tracked appropriately. Providing oversight and liaise with regulator affairs associate assigned to the project to ensure MoH submission is performed as applicable.Responsible for providing oversight of local/central Ethics Committee submission and tracking. responsible for providing progress reports for country start-up performance metrics to CTM. Participate in IP release processConducting 2nd pass document review as needed. Insuring that all In-House CRAs, CRAs, CAs are kept current on timelines, clinical activities, contract- & budget status. Responsible in achieving successful delivery of start-up activities implementing start-up methodology in a consistent manner as well meeting company and Client's study requirements. Reviewing ED to ensure Client & investigator obligations are being met in compliance with applicable local regulatory requirements and ICH guidelines. Ensure that all task meet Client and company expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP and applicable SOPs

Responsible for start-up of clinical trials in Scandinavia. This includes: recruiting sites, ethics committee submissions, essential document collection and review, investigator contracts, study and site status tracking, etcMaintenance of clinical trials in Scandinavia: amendment submissions to ethics committee, essential document collection and review, etc. Clinical status tracking and in-house site management activities for PRA clients’ clinical research projects, phase II-IV. Ensures that all tasks meet client and PRA expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP and applicable Standard Operating Procedures (SOPs).

Responsible for start-up of clinical trials in Scandinavia. This includes: recruiting sites, ethics committee submissions, essential document collection and review, investigator contracts, study and site status tracking, etcMaintenance of clinical trials in Scandinavia: amendment submissions to ethics committee, essential document collection and review, etc. Clinical status tracking and in-house site management activities for PRA clients’ clinical research projects, phase II-IV. Ensures that all tasks meet client and PRA expectations, and are delivered in accordance with the contract, trial protocol, ICH-GCP and applicable Standard Operating Procedures (SOPs).

Responsible for planning and conducting phase I clinical trials in accordance with protocol, SOP's, local regulations and ICH/GCP requirements.

Sterile cell culturing. Cyto-genetic analyses of blood-, amniocenteses- and chorion samples.

Blood component manufacturing (platelets, erythrocyte, plasma). Evaluation/assessment of blood donors health declaration. Blood donation tasks. Blood sample handling such as general clinical chemistry- and heamatology blood samples.

Stockholm, Sverige

Marketing of the Swedish Association for Health Professionals on a national basis at Job Market Venues organised by Universities and University Collages in Sweden. Support biomedical scientist student by organising national meetings/forums.

Gcp Training

Msc, Biomedical Science, Biomedical Laboratory Science

Bsc, Biomedical Laboratory Science