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 (i e 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.
Builds and maintains strategic partnerships with internal stakeholders (e g, Clinical Research, Affiliates) and external collaborators (e g, CROs, AROs).
Qualifications:
Specific Knowledge, Skills, Abilities:
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.
Stakeholder Vendor Engagement Builds strong relationships with internal and external stakeholders.
Manages communications, escalations, and alignment across functions and geographies.
Clinical Regulatory Expertise Demonstrates deep knowledge of clinical trial phases, therapeutic areas, and regulatory requirements.
Ensures readiness for submissions and compliance with global standards.
Systems Data Management Utilizes CTMS and other clinical 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.
Builds consensus and fosters an inclusive, high-performing culture.
Critical Thinking Decision Making Solves complex problems and makes timely, informed decisions that prioritize patient safety and data integrity.
Accountability Results Focus Owns outcomes, ensures quality, and delivers on time and within budget through proactive 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 7 years of experience clinical operations roles and project management in the pharmaceutical or healthcare industry, including multi-national experience.
Experience in independently leading complex global clinical trials, demonstrating strong knowledge of the study and program strategy.
Experience leading global and multi-functional teams.
Experience in managing CROs, not mandatory
Travel requirement: up to 25%
With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
