The Clinical Research Scientist (CRS)/Sr. CRS will support US efforts in the planning, execution and reporting of US CD&MA clinical trials in Oncology/Hematology. Responsible for implementation of operational aspects of oncology clinical development and medical affairs trials in the United States (phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use). Support all scientific aspects of clinical trial(s) and program level activities as assigned and lead a cross functional team with oversight from the Director. Interfacing with the oncology therapeutic area global and U.S. clinical team members, clinical operations, scientific operations, regulatory affairs, drug supply, data management, and finance and other relevant functional areas to execute day to day activities of clinical trials. Serve as U.S. Local trial lead for multiple global clinical development trials and/or non- registration U.S. Medical Affairs. Drive study enrollment, plan advisory boards, and perform external study feasibility with investigators. Contributing to the preparation and review of clinical program documents (PowerPoint presentations, IND annual report, Health Authority (HA) briefing books, clinical study protocol, regulatory documents, clinical study reports, (CSR) and submissions) and other study related documents assuring quality and consistency. Plan and presenting in written and oral format monthly: group productivity, project status and key deliverables to senior management. . Contributing to multidisciplinary task forces to support continuous improvement in SOPs. . Liaise with study investigators, site research staff , and field based colleagues to support clinical studies through customer service, creative support, and financial reimbursement. Support the development, management and tracking of trial budget working closely with the appropriate partners. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
BA/BS degree required. Minimum 3 years of clinical research experience required. Experienced working with pharmaceutical sponsored clinical studies required. CRO vendor management experience required. 20% travel required Position will be filled at level commensurate with experience. Novartis is an EEO/AA employer. M/F/D/V
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