Daniela Dorta

Background

About Daniela Dorta

Over 18 years working in Clinical Research as Clinical Research Associate, Lead CRA, Project Leader, Project Manager and Oversight Manager of Pharmaceutical companies and CROs. Strong background in clinical monitoring experienced in all aspects of project phases from site selection to close-out in Rare Diseases, Ophthalmology, Oncology, Pain Managment, Cardiology, Nephrology,Endocrinology and Respiratory therapeutic areas.Experience in big multicenter trials ensuring that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements Experienced in global trials as CRA and LCRA in key oncology indications ( lymphoma, melanoma, prostate, breast, multiple myeloma and lung cancer) including immunotherapies and biologicals Experience as Lead CRA for global studies, coordinating CRAs and reviewing monitoring reports. Active participation in BID defenses with sponsors and presentation of the company locally for local offices of pharmaceutical companies. Previous experience as CRA in US and Portugal region for 3 months each experience. Experience in Quality Assurance roles including QA Consultant and Lead GCP Auditor.