Responsibilities included: • General Management/Line Management of Research Drive BV • International Project management and project design • International Data Management coordinator • Coordinating and monitoring, co-monitoring, • Regulatory and EC submissions different therapeutic areas, phases and countries • International Site management of phase I-IV studies • International contract negotiation. • Assisting in training on Good Clinical Practice of CRAs on study protocols/monitoring of phase I clinical studies. Indications: Multiple myeloma, device study in breast reduction/total body lifts, stress incontinence, solid tumors, cardiology, rhEPO, Cystic Fibrosis, oncology trials (breast, prostate, solid tumors, AML), Hemophilia A, AL amyloidosis, Pyruvate Kinase Deficiency, renal and bone marrow transplantation, COPD, EPO trials in phase I and oncology, Asthma, COPD, Cystic Fibrosis, SAB (aneurysma subarachnoid hemorrhage) and severe COPD. Activities: eCR
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