Duties: The Senior Clinical Research Scientist (SCRS) will support in the planning, execution and reporting of US CD&MA clinical trials in Oncology/Hematology/Rare Disease/Early Therapeutics. Responsible for the implementation of designated clinical trials including investigator selection, patient recruitment, preparation of trial related documentation (protocols, Case report forms, consent documents, letters of agreement, confidentiality agreements), and organizing Ethics committee submissions. Track and manage key trial indicators including: monthly project status, key deliverables to senior management. Accountable for the accuracy and timeliness of trial information in all trial databases and tracking systems. Serve as U.S. Local trial lead for multiple global clinical development trials and/or non-registration U.S. Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use). Understand and comply with company SOPs and GCP's; contribute to continuous improvement in SOPs and local Working Practices. Skills: Ability to evaluate medical research data and proficient knowledge of medical terminology. Ability to utilize problem-solving techniques applicable to constantly changing environment. Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software. Education: Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/ licensure from an appropriately accredited institution Required experience: clinical research, oncology, clinical trials phase I-IV, clinical operations: 3 years ()
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