Senior Global Trial Specialist

About the role

Challenging. Meaningful. Life-changing. Transforming patients’ lives through science.

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.

Responsibilities

• 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.

Requirements

• Bachelor’s degree or foreign equivalent in Healthcare, Nursing, or a related field, and five (5) years of progressive post-baccalaureate related work experience.
• Experience in the following skills:
• 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.
• 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 Good Clinical Practice (ICH/GCP); and CRO oversight and considering the partnership level agreement for each study to assure compliance with the protocol and Standard Operational Procedures.

Benefits

• Health Coverage Medical, pharmacy, dental, and vision care.
• Wellbeing Support Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Pay

$118,446.00 - $140,120.00

Schedule

Telecommuting permitted up to 2 days per week. Up to 5% domestic travel may be required based on business need.