Senior Global Trial Specialist

Working with Us Challenging. 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. 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. Employer: Bristol-Myers Squibb Company Job Title: Senior Global Trial Specialist Location: 3401 Princeton Pike, Lawrenceville, NJ 08648 Wage Range: $118,446.00 - $140,120.00 Bristol-Myers Squibb Company is hiring a(n) Senior Global Trial Specialist (in Lawrenceville, NJ). Duties: Contribute to the operational execution of clinical research studies from protocol development to final clinical study report. Ensure deliverables are on-time, within budget, and comply with applicable regulations and standard operation procedures. Edit and submit protocols and other required research documentation. Support clinical research study start-up, maintenance, and closure activities. Provide operational input and facilitate operational processes. Prepare, manipulate, and manage extensive databases. Verify the accuracy and validity of data entered in databases, correcting any errors. Perform descriptive and multivariate statistical analyses of data, using computer software. Participate, set-up agendas, and capture meeting minutes in study team meetings for assigned protocols. Track nonclinical supplies and expenses such as site payment processing. Telecommuting permitted up to 2 days per week. Up to 5% domestic travel may be required based on business need. Requirements: Employer will accept a Bachelor’s degree or foreign equivalent in Healthcare, Nursing, or a related field, and five (5) years of progressive post-baccalaureate related work experience. Must have five (5) years of experience in the following skills (which may be gained concurrently): \- Creation and Maintenance of Study Related Mail Groups, Study Share Points, Transfer of Obligations, Enrollment Trackers, Study Contact List, Financial Disclosure Forms, Subject Alert Cards, Study newsletters, Global Study Team Meeting Minutes, Global Vendor Site List /Vendor Management (Mitigating vendor challenges to adopt the GVSL); and \- Management of study related meetings including Global Study Team Meetings, Investigator Meetings, Data Monitoring Committee Meetings, Clinical Safety Review Meetings, Study Steering Committee Meetings. Must have two (2) years of experience in the following skills (which may be gained concurrently): \- Using Clinical Trial Management Systems (CTMS) including Study Creation and Set Up, Milestones Review/Updates, Data Quality Dashboard Reports, Study Team Updates, Study Closure Activities, Managing integration of safety vigilance systems (CelAlert/Study investigator Platform); \- Using Clinical Trial Master File (TMF) systems including Creation of Core Study Documents and Plans which includes Vendor Trial Oversight Plans (VTOP), Trial/Project Management Plan, Conducting Quarterly TMF reviews, Creation and Management of Study Specific TMF Master List, TMF Plans, Communication Plan and Expected Document List, Inspection Preparation, TMF Archival Management, Responses to Audit Findings/ CAPA; \- Designing and reporting clinical trials involving human participants in compliance with the International Conference on Harmonisation's Guideline for...