Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:careers.bms.com/working-with-us.Job DescriptionWork closely with clinical team members within the assigned project to execute assigned activities associated with the conduct of a clinical trialMay lead or support trial level activities for one or more trials with a level of supervision.Responsibilities include, but are not limited to:Literature reviewDevelopment of Protocol and ICF documents / amendments, and may present these to governance committee and development team meetingsSubmission of clinical documents to TMFDevelopment of site and CRA training materials and presentation at SIVs and Investigator meetings.Review clinical narrativesMonitor clinical data, issue and resolve data queriesMonitor clinical data for specific trendsDevelops Data Review Plan in collaboration with Data ManagementResponsible for ensuring CRF design adequately supports collection of data in alignment with the protocol in collaboration with DataManagement/ProgrammingSite-interface in collaboration with trial physician as point of contact for clinical questionsClinical 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.))Support study committee (e.g., DMC, Steering Committee, Advisory Board, etc) logistics and presentation developmentMay co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross functional study team membersCollaborate and liaise with external partners (EG, KOLs, etc) for scientific adviceSeek out and enact best practices with instructionProvide regular and timely updates to manager/management as requestedRequirementsBasic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operationsAbility to understand assigned protocol(s) and their requirementsDetail-oriented with commitment to qualityBasic knowledge and skills to support program specific data review and trend identificationBasic knowledge of disease area, compound, current clinical landscapeBasic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees Intermediate medical writing skills and medical terminologyIntermediate critical thinking & problem solving skillsAdaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)Basic planning/project management skills (develop short range plans that are realistic and effectiveModerate skills in MicrosoftWord/Excel/PowerPointand data review tools (e.g., Pt Profiles, report generating tools)Degree in Life Sciences (MD, PhD with 0-2 years of prior clinical research experience, or PharmD, MS, RN or other scientific degrees with at least 2 years of clinical research experience preferred). If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith 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 an inclusive culture, promoting diversity 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 ProtocolBMS has a diverse 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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto 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.
