Bristol Myers Squibb
Healthcare
AssociateDirector,GlobalTrialLead
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“Associate Director, Global Trial Lead at Bristol Myers Squibb. Skills: Global Trial Management, Operational Oversight, Risk Management, Stakeholder Engagement. Spearhead collaboration with study teams and vendors. Ensure clinical trial delivery meets timelines”
What You'll Achieve.
Ensure clinical trial delivery meets timelines; Ensure clinical trial delivery meets budgets; Ensure clinical trial delivery meets quality benchmarks; Ensure alignment with contractual terms; Ensure alignment with budgetary targets; Ensure alignment with quality standards; Optimize trial execution; Ensure timely and high-quality deliverables; Ensure financial accuracy; Ensure financial efficiency; Ensure trial continuity; Ensure patient safety; Ensure regulatory compliance; Ensure data quality; Ensure system integrity
Industry & Context.
Risk identification; Risk management; Issue identification; Issue resolution; Problem solving; Root cause analysis
What They're Looking For.
Must Have
Global clinical trials expertise, Trial operations management, Budget management, Risk mitigation, GCP/GXP compliance, Vendor management, Clinical trial phases knowledge, Regulatory requirements knowledge, CTMS system utilization
Nice to Have
Master's degree
What You'll Do.
Spearhead collaboration with study teams and vendors
Ensure clinical trial delivery meets timelines
Ensure clinical trial delivery meets budgets
Ensure clinical trial delivery meets quality benchmarks
Provide strategic input on study feasibility
Oversee operational activities of contributors
Identify and manage risks
Balance trade-offs between cost
Manage scope of work for CROs and vendors
Ensure alignment with contractual terms
Ensure alignment with budgetary targets
Ensure alignment with quality standards
Participate in vendor selection
Participate in vendor evaluation
Review vendor invoices
Approve vendor invoices
Reconcile vendor invoices
Review vendor accruals
Approve vendor accruals
Reconcile vendor accruals
Review vendor scope amendments
Approve vendor scope amendments
Reconcile vendor scope amendments
Utilize performance metrics to monitor execution
Utilize quality indicators to monitor execution
Optimize trial execution
Maintain accurate data records
Ensure accurate data records
Develop trial-specific standards
Enforce trial-specific standards
Promote operational consistency
Lead development of best practices
Lead execution of best practices
Establish study-level project management tools
Maintain study-level project management tools
Collaborate cross-functionally for knowledge sharing
Collaborate cross-functionally for information sharing
Offer therapeutic guidance on study protocols
Offer operational guidance on study protocols
Offer therapeutic guidance on execution strategies
Offer operational guidance on execution strategies
Provide consultation on risk mitigation
Provide consultation on operational excellence
Monitor trends in clinical operations
Advise teams on proactive responses
Mentor global GDO Study Team members
Support development of others
Drive upfront planning of study timelines
Drive upfront planning of study budgets
Manage program-level vendor logistics
Escalate resourcing needs appropriately
Identify issues impacting budget adherence
Resolve issues impacting budget adherence
Identify issues impacting timeline adherence
Resolve issues impacting timeline adherence
Lead quarterly budget reviews
Flag anticipated variances for trials
Collaborate with Finance on forecasting
Oversee strategic planning of clinical trials
Oversee execution of clinical trials
Ensure timely deliverables
Ensure high-quality deliverables
Provide lifecycle leadership
Provide lifecycle oversight
Lead cross-functional Study Teams
Coordinate with clinical departments
Coordinate with development departments
Analyze operational metrics
Optimize study execution
Ensure alignment with franchise objectives
Identify organizational challenges
Identify procedural challenges
Propose actionable solutions
Build strategic partnerships with internal stakeholders
Build strategic partnerships with external collaborators
Lead global clinical trials
Ensure regulatory compliance
Ensure patient safety
Ensure timely delivery of data
Ensure high-quality data delivery
Drive project outcomes through coordination
Drive project outcomes through progress tracking
Manage end-to-end trial operations
Manage site selection
Manage vendor coordination
Manage resource planning
Oversee cost optimization
Ensure financial accuracy
Ensure financial efficiency
Ensure trial continuity
Support audit readiness
Build relationships with internal stakeholders
Build relationships with external stakeholders
Manage communications
Manage alignment across functions
Manage alignment across geographies
Demonstrate deep knowledge of clinical trial phases
Demonstrate deep knowledge of therapeutic areas
Demonstrate deep knowledge of regulatory requirements
Ensure readiness for submissions
Ensure compliance with global standards
Utilize CTMS to track milestones
Utilize other clinical systems to track milestones
Utilize CTMS to ensure data quality
Utilize other clinical systems to ensure data quality
Utilize CTMS to support decision-making
Utilize other clinical systems to support decision-making
Partner with technical teams to maintain system integrity
Drive cross-functional teams toward shared goals
Foster an inclusive culture
Foster a high-performing culture
Solve complex problems
How You'll Work.
Team & Collaboration
Internal study teams; Vendors; Cross-functional teams; Global GDO Study Teams; Cross-functional Study Teams; Internal stakeholders; External collaborators; CROs; AROs; Clinical departments; Development departments; Finance; Technical teams
Communication Scope
Knowledge sharing; Information sharing
Process & Methodology
Project Management, Scope of Work (SOW), Vendor Management, Performance Metrics, Quality Indicators, Study Management Systems, Project Management Tools, Action Logs, Decision Trackers, Issue Registers, Risk Mitigation Plans, Budget Management, Resource Planning, Forecasting, Lifecycle Leadership, Study Execution Analysis, Strategic Planning
Full Job Description
**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](https://careers.bms.com/working-with-us). _**Key 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 a
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