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Job description
Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct. May serve as Clinical Trial Lead for one or more trials. May lead or support trial level activities for one or more trials with the necessary supervision.
Collaborate and liaise with external partners (e.g., KOLs), seek out and enact best practices with instruction, provide regular and timely updates to manager/management as requested, develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required, conduct literature review, submit clinical documents to TMF, develop site and CRA training materials and present these at SIVs and Investigator meetings, review clinical narratives, monitor clinical data for specific trends, develop Data Review Plan in collaboration with Data Management, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming, submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry), basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations, ability to understand assigned protocol(s) and their requirements, basic knowledge skills to support program-specific data review and trend identification, intermediate medical writing skills and medical terminology, basic planning/project management skills (develop short range plans that are realistic and effective), detail-oriented with commitment to quality, basic knowledge of disease area, compound, current clinical landscape, basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees, intermediate critical thinking and problem-solving skills, priorities; ability to meet day-to-day challenges with confidence and professionalism)
Company
Healthcare
Bristol‑Myers Squibb (BMS) is a global biopharmaceutical leader dedicated to discovering, developing, and delivering innovative medicines that address serious diseases such as cancer, immunologic disorders, cardiovascular conditions, and fibrosis. Leveraging deep scientific expertise and a robust pipeline of novel therapies, BMS combines cutting‑edge research with rigorous clinical development to bring transformative treatments to patients worldwide. The company’s value proposition lies in its commitment to scientific excellence, patient‑focused outcomes, and collaborative culture, offering employees the opportunity to contribute to breakthrough medicines that improve lives. BMS provides a dynamic environment for professionals seeking to advance their careers in drug discovery, clinical research, regulatory affairs, and commercial operations while making a meaningful impact on global health.
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