Senior manager, Clinical Scientist

Description  The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. Position Summary / Objective 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 May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members Position Responsibilities 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 Requirements Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). MD-Pharmacology preferred Experience Requirements 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) Key Competency Requirements 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 Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism) Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools) Travel Required Domestic and International travel may be required. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.