Dr. Monika Kouba

EU Director Clinical Operations for Halozyme Inc., a Amplity Health (previously Tardis Medical consultancy) client based in San Diego, representing Halozyme in EMEA, responsible for clinical trial oversight for a large phase 3 pancreatic cancer trial.

Management of various projects e.g supporting the launch of the first biosimilar of Infliximab (Rheumatoid Arthrtis, Spondylitis, Psoriasis, Ulcerative Colitis, Morbus Crohn) in Switzlerland, set up of a breast cancer trials in Eastern Europe, set up of Case report forms for a medical device from US in wound management.

Line Management of Senior CPMs. Project management for newly awarded projects. Participate in business development by leading proposal development and bid defense meetings, mainly Rare disease indications, biosimilar phase 3 trials in rheumatoid arthritis, and cardiovascular and oncology indications.

Management of Clinical Trials worldwide for US based clients. Execution of global cardiovascular trials (client budgets and contracts, submissions, contracts with sites, monitoring, recruitment strategies). Managing Clinical Project managers directly and a clinical team within an matrix organization.

Management of Projects in critical care indications phase 1-4 and IITs. Mainly cardiovascular trials.

Management of clinical trials Phase 2-4 in various indications in Central Eastern Europe and Middle East

Umsetzung Klinischer Studien, Teamleiterin eines Entwicklungsteams mit PriceWaterhouseCoopers

Molekularbiologie, Genetik, Immunologie