During the summer we have been joined by 6 new consultants. This group of consultants really puts the Pharma in Pharma IT. We invite you to meet the newest joiners.
Maria Wriedt Jakobsen holds more than 10 years’ experience in the pharmaceutical industry working with Trial Management both as Trial Manager and as Project Manager. Experience with writing protocols, oversight plans, risk management plans including risk-based monitoring, communication plans and executing investigator meetings, monitor meetings and internal company clinical trial meetings.
Mike Astrup Nygaard holds experience from several pharmaceutical companies, working with various compliance and test assignments within GxP. Mike is experienced in taking lead and ownership of all types of compliance tasks from user requirement specifications, to validation plans, testing and reporting.
Lene Hyldgaard Jensen holds more than 10 years’ experience in the pharmaceutical industry working in various business partnering roles, preparing business analysis, facilitating workshops, transforming business requirements into IT development and implementation projects and delivering subject matter expert assignments, especially in the Regulatory area
Evangelos Kapris is an experienced Clinical Data Manager. He brings insights into CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk-based monitoring and data management oversight.
Faiyaz Hussein has 15 years of Clinical Research Experience with respect to Project Management, Data management, eCRF and database designing, validation of IT systems, integration testing, reporting on varied EDC systems, electronic patient reported outcomes ePRO, edevices in diabetes care (Insulin pumps, CGM) and submission to Health Authorities with major pharmaceuticals.
Torben Elhauge holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area. With an offspring in Analytical development, Torben has a broad experience within all parts of the CMC area from development over validation and registration to GMP release of products
A warm welcome to all of you!
Pharma IT consists of highly experienced people as well as young talents and we invite you to take a closer look at our TEAM