Associate Director, Global Trial Lead

21 hours ago


Hyderabad Telangana, India Bristol-Myers Squibb Full time

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 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 If you come across a role that intrigues you but doesn t perfectly line up with your resume we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work Life-changing Careers With a single vision as inspiring as Transforming patients lives through science TM 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 On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential site-by-design field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role Site-essential roles require 100 of shifts onsite at your assigned facility 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 Applicants can request a reasonable workplace accommodation adjustment prior to accepting a job offer If you require reasonable accommodations adjustments in completing this application or in any part of the recruitment process direct your inquiries to Visit to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff customers patients and communities As a result the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations



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