Global Trial Acceleration Associate

Bristol Myers Squibb is seeking a Global Trial Acceleration Associate to manage and execute on centralized activities in support of global trials with an emphasis on clinical documentation. The role involves interacting with clinical study sites, CROs/vendors, Country Trial Managers, and other functional areas within BMS, as well as developing and maintaining collaborative working relationships with relevant stakeholders.

Requirements

• Minimum of a bachelor’s degree in legal, Life science, Business Administration, or equivalent experience
• Minimum 3 years of relevant clinical development & operational experience in Pharmaceutical, biotech, CRO or similar fields, is required
• Seasoned field monitor with min 3+ years of global site monitoring (Clinical Research Associate) report review experience is preferred
• Prior therapeutic area expertise (eg: Oncology, Cardiology, Hematology, Immunology etc) is preferred
• Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies; including formulating responses to queries
• Hands-on experience of preparing, reviewing, and submitting clinical study start-up / activation documentation, including responses to queries
• Knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma
• Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals
• Effective communication skills in English (written & oral), computer skills - MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred, knowledge of portals, databases and other Clinical Trial enabling technologies

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance