Pharma IT clinical trials and operation is expanding.

The clinical trials and operation department at Pharma IT is expanding. Now covering experts from early phase to late phase including experience from small biotech companies to big pharma as well as experience from CRO and academia.

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Maria Wriedt Jakobsen – Clinical Project and Trial Manager, Senior Pharma Consultant

Senior Clinical Trial Manager and Project Manager with more than 13 years operational and strategic experience with planning, overseeing and managing international clinical trials. Experience with authoring clinical trial protocols, oversight plans, risk management plans including risk-based monitoring, communication plans and executing investigator meetings, monitor meetings and internal company clinical trial meetings. As well as very experienced with vendor and stakeholder management.

Academic background as Cand. Pharm and working experience in diabetes, hematology, dermatology, neurology, oncology as well as orphan diseases.

Berit GrevstadClinical Project and Trial Manager, Pharma Consultant

Experienced international clinical trial manager and site manager from Clinical Research Organizations and Academia.  Experienced in start-up of multinational Phase I – IV clinical trials, including development of trial related documents such as trial protocols, risk management plans, monitoring plans and eCRFs.

Academic background as project manager in infectious disease areas (HIV, Malaria, Ebola) and working experience in infectious diseases, vaccine development, immunology, hematology, oncology, diabetes, cardiovascular, respiratory, and neuroscience disease areas.

Birgitte Sloth  – Clinical Project and Trial Manager, Senior Pharma Consultant

Experienced Clinical Scientist, Trial and Project Manager with more than 15 years of experience with scientific, operational and strategic parts of project and trial management, functioning as Global Study Lead and Clinical Project Scientist. Extensive experience with vendor and stakeholder management, protocol authoring, management of clinical trial teams, and clinical project management within early phase clinical development including phase I-II and phase III in a rare disease indication.

Academic background in metabolic disease area and working experience in obesity, diabetes, cardiovascular, immunology, dermatology, respiratory, musculoskeletal and neuroscience disease areas.

Experience within translational medicine, pediatric investigational plans, NDA submission.

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