• Global clinical studies experience with cross-functional teams• Early phase clinical studies management• Oncology and rare disease clinical trial management • 10+ years of experience in clinical trials• Study Start Up (SSU) activities for phase I, II, III and post-marketing clinical trials in the areas of oncology, diabetes, obesity, dermatology, neurology, genetics, liver and kidney disease• FDA regulations, GCP and ICH guidelines for the conduct of clinical research• Vendor management• Classify, contain Quality Issues and escalate to Quality Assurance for resolution• Quality Control and SOP revision• Trial Master File, ClinicalTrial.gov revisions and postings• IRB/IEC application preparation and submission • Clinical research protocols and protocol amendments review• Country and Site-specific templates Informed Consent Form writing and revision • Regulatory documents (Form FDA 1572, CDA, fully executed contracts, financial disclosures, insurance) • Ability to negotiate and manage competing priorities across multiple functional areas.