Bristol Myers Squibb

- The Global Trial Lead (GTL) provides strategic and operational oversight for global clinical trials, ensuring they are executed with excellence-on time, within budget, and in compliance with regulatory standards and internal policies.- This role serves as a key leader within Global Development Operations (GDO), contributing to study-level strategy, cross-functional alignment, and issue and risk resolution.- The individual guides trial execution across all phases and manages relationships with vendors to uphold performance and quality.- This role may also lead global initiatives, support Operational Portfolio Leads on asset, trial and/or therapeutic-level inquiries, and influence decision-making at both study and organizational levels.- The Global Trial Lead plays a pivotal part in driving delivery of registrational and non-registrational studies, with broad impact across therapeutic areas and global teams.- Note: The Global Trial Lead (GTL) role has several levels, activities listed with an - are specific to the AD, GTL role. Duties And Responsibilities:- Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following:. Project Management:- Spearheads collaboration with internal study teams and vendors to ensure clinical trial delivery meets established timelines, budgets, and quality benchmarks.- Provides strategic input on study feasibility and oversees operational activities of internal and external contributors.- Identifies and proactively manages risks, balancing trade-offs between cost, deliverables, and quality.- Manages scope of work (SOW) for CROs and Vendor Partners, ensuring alignment with contractual terms, budgetary targets, and quality standards.- Participates in vendor selection and evaluation processes.- Reviews, approves, and reconciles vendor invoices, accruals, and scope amendments.- Utilizes performance metrics and quality indicators to monitor and optimize trial execution.- Maintains and ensures accurate data records in study management systems such as Veeva (CTMS, eTMF, etc.- Develops and enforces trial-specific standards aligned with broader portfolio strategies to promote operational consistency.- Leads development and execution of cross-functional and global best practices.- Establishes and maintains study-level project management tools, including action logs, decision trackers, issue registers, and risk mitigation plans.- Collaborates cross-functionally to ensure timely knowledge and information sharing.- Study Input & Strategic Guidance.- Offers therapeutic and operational guidance on study protocols and execution strategies.- Provides consultation across programs/studies with a focus on risk mitigation and operational excellence.- Monitors trends in clinical operations and advises teams on proactive responses.- Mentors global GDO Study Team members within assigned therapeutic areas and others, as applicable.- Supports the development of others within the department and/or enterprise- Budgeting & Resource Planning.- Drives upfront planning of study timelines and budgets in partnership with cross-functional teams.- Manages program-level vendor logistics and escalates resourcing needs appropriately.- Identifies and resolves issues impacting budget and timeline adherence.- Leads quarterly budget reviews, flagging anticipated variances for assigned trials and collaborating with Finance on forecasting. Program & Study Oversight:- Oversees strategic planning and execution of multiple clinical trials, ensuring timely and high-quality deliverables.- This may include program/study oversight for multiple clinical trials.- Provides lifecycle leadership and oversight from start-up to close-out phases.- Leads cross-functional Study Teams and coordinates with clinical and development departments.- Analyzes operational metrics to optimize study execution and ensure alignment with franchise objectives.- Identifies organizational and procedural challenges, proposing actionable solutions.Technical Competencies:- Global Trial & Project Management Leads global clinical trials with expertise in planning, execution, and oversight.- Ensures regulatory compliance, patient safety, and timely delivery of high-quality data.- Drives project outcomes through strategic coordination and progress tracking.- Operational & Budget Oversight Manages end-to-end trial operations, including site selection, recruitment, vendor coordination, and resource planning.- Oversees budgets, forecasts, accruals, and cost optimization to ensure financial accuracy and efficiency.- Risk & Quality Management Identifies and mitigates risks to ensure trial continuity.- Maintains GCP/GXP compliance and supports audit readiness with a strong quality mindset.- 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. 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