Global Trial Lead (multiple openings)
Job Location:
Princeton, NJ - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At Bristol Myers Squibb our employees often ask Who are you working fora question that fuels collaboration accountability and urgency in our work. Our purpose-driven culture inspires us to discover develop and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work opportunities for growth and a supportive environment that values inclusion wellbeing flexibility and comprehensive benefits. This is work that transforms the lives of patients and the careers of those who do it.
The Global Trial Lead (GTL) provides full end-to-end operational accountability and oversight for global medical studies ensuring they are executed with excellence on time within budget and in compliance with regulatory standards and internal policies. This role serves as the single accountable operational owner within MEG Operations working in close partnership with the MEG Lead who holds accountability for study design and clinical trial medical oversight. The GTL is responsible for all operational execution across all study phases and manages relationships with vendors to uphold performance and quality. This role may also lead global initiatives and directly represent operational execution at asset- and therapeutic-level governance forums influencing operational decision-making at both study and organizational levels. The Global Trial Lead plays a pivotal part in driving delivery of medical studies with broad impact across therapeutic areas and global teams.
This role reports to the MEG Operations Lead within MEG Operations.
Responsibilities
1. Project Management
- Holds singular operational accountability for medical study delivery partnering closely with the MEG Lead and internal study teams to ensure execution meets established timelines budgets and quality benchmarks
- Directly oversees all operational activities of internal and external contributors with no delegation of primary operational accountability to a CRO or external party
- Identifies and proactively manages risks balancing trade-offs between cost deliverables and quality
- Owns and manages the 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 study execution
- Ensures accurate data records in study management systems such as Veeva (i.e. CTMS eTMF etc.)
- Develops and enforces study-specific operational standards aligned with broader portfolio strategies to promote 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
2. Study Input & Operational Guidance
- Offers operational guidance on study execution strategies working in close alignment with the MEG Lead on protocol design and clinical/medical oversight matters
- Provides consultation across programs/studies with a focus on risk mitigation and operational excellence
- Monitors trends in medical and clinical operations and advises teams on proactive responses
3. Budgeting & Resource Planning
- Owns upfront planning of study timelines and budgets in partnership with cross-functional teams
- Directly manages all study-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 studies and collaborating with Finance on forecasting
4. Study Oversight
- Bears full lifecycle operational accountability for assigned study/studies from start-up through close-out phases with no split or shared ownership of operational outcomes
- Acts as the primary point of escalation for all study operational matters within MEG Operations escalating clinical and medical questions to the MEG Lead as appropriate
- Works closely with MEG Operations MEG and cross-functional teams to ensure administrative tasks are appropriately executed upon (e.g. eTMF document upload and periodic reviews CTMS maintenance finance reconciliation and hygiene)
Qualifications
Technical Competencies
- Medical Study & Project Management Leads global medical studies with expertise in planning execution and full operational ownership. Ensures regulatory compliance patient safety and timely delivery of high-quality data. Drives study outcomes through operational coordination and progress tracking in close partnership with the MEG Lead.
- Operational & Budget Oversight Manages end-to-end study 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 operational risks to ensure study continuity. Maintains GCP/GXP compliance and supports audit readiness with a strong quality mindset.
- Stakeholder & Vendor Engagement Builds strong relationships with internal and external stakeholders including the MEG Lead and cross-functional partners. Manages communications escalations and alignment across functions and geographies.
- Clinical & Regulatory Expertise Demonstrates knowledge of clinical trial phases therapeutic areas and regulatory requirements. Ensures operational readiness for submissions and compliance with global standards.
- Systems & Data Management Utilizes CTMS and other clinical/medical systems to track milestones ensure data quality and support decision-making. Partners with technical teams to maintain system integrity.
Management Competencies
- Leadership & Collaboration Drives cross-functional teams toward shared goals while maintaining clear personal accountability for all study operational outcomes. Builds consensus and fosters an inclusive high-performing culture through strong partnership including with the MEG Lead.
- Critical Thinking & Decision Making Solves complex operational problems and makes timely informed decisions that prioritize patient safety and data integrity.
- Accountability & Results Focus Fully owns all study operational outcomes ensures quality and delivers on time and within budget through proactive hands-on oversight.
- Adaptability & Resilience Responds effectively to change and manages conflict constructively while maintaining team morale.
- Communication & Relationship Building Communicates clearly across global teams and builds strong trust-based relationships with diverse stakeholders.
Education/Experience/Licenses/Certifications
- BA/BS or equivalent degree in relevant discipline.
- Minimum 4 years of experience in clinical/medical operations roles and project management in the pharmaceutical or healthcare industry including multi-national experience.
- Experience in leading global clinical/medical trials with strong project management/organizational skills and presentation and communication abilities.
- Experience leading global and multi-functional teams in a matrixed environment.
- Experience in managing CROs preferred.
- Travel requirement: up to 25%.
We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.
Compensation Overview:
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully carefully considering the nature of the role required skills work location schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors and individual team or Company performance.
Benefits:
Subject to the terms and conditions of the applicable plans then in effect you may be eligible to participate in our comprehensive benefit plans including wellbeing support retirement and financial protection benefits and insurance offerings (medical dental vision life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO) which provides paid time off without a set accrual limit subject to manager approval along with 11 paid company holidays each year.
Non-exempt employees RayzeBio employees and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval) 11 paid company holidays and 3 optional holidays.
Depending on eligibility employees may also have access to additional time-off benefits including paid sick leave up to two paid volunteer days per year summer hours flexibility and leaves of absence for medical personal parental caregiver bereavement or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Years Day.
U.S.-based job seekers can explore full benefit offerings at We Work
Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities
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R: Global Trial Lead (multiple openings)
About Company
Bristol-Myers Squibb is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Our medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immu ... View more
