At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a 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.
Working with Us
Challenging. Meaningful. Life-changing. Those are not 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 will get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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 .
Position Summary
The Global Trial Acceleration Associate (GTAA) plays a significant role in delivering centralized clinical operations activities, contributing to the acceleration of clinical trial start‑up and regulatory processes through standardized execution within the Global Trial Acceleration Center (GTAC).
This role operates with a high degree of independence and expanded accountability, supporting complex global studies and BMS portfolios. This role requires cross cultural stakeholder engagement across multiple functions.
Key Responsibilities
- Independently manage and execute centralized clinical trial start‑up activities across assigned studies and countries.
- Preparation, collection, review and approval of clinical trial package documents in accordance with project plan, SOP/ Work instructions, applicable global and local regulations.
- Country and site‑level Informed Consent Form (ICF) adaptation and negotiation(s) with sites, ensuring alignment with protocol, local regulations, and Ethics Committee requirements and applicable SOP and Work instructions.
- Prepare, compile study dossier for Ethics Committee (EC/IEC) submission, including initial submissions, amendments, and may coordinates responses to EC queries.
- Prepare and deliver Onsite Investigator site file as per project plan and applicable SOP and Work instructions.
- Process site invoices as per executed CTAg (Clinical Trial Agreement) and EDC (electronic data capture).
- Create, adjust and close site, local IRB and HA purchase order as per applicable process, SOP and Work instructions.
- Procure and deliver study/ site Insurance from BMS approved vendor as per project requirement, applicable SOP and Work instructions.
- Support study feasibility site selection through performing debarment check of potential Investigators across countries and region
- Distribution of Clinical Study Reports (CSR) and Plain Language Summary (PLS) to study sites.
- Manage and provide operational support to study GTL and OM for Patient Engagement and Recruitment (PER) work and in PER vendor selection for the study.
- Support EU-CTR submissions as per applicable SOP and Work instructions.
- Manage, coordinate Subject Related Injury (SRI) re-imbursement as per applicable process, SOP and Work instructions.
- Manage and support other applicable task as per business requirements
- Ensure adherence to applicable SOPs, Work Instructions, GCP, first time quality of deliverables, timelines and GTAC KPIs across all assigned activities.
- Maintain accurate, complete, and inspection‑ready documentation within CTMS, eTMF, and other clinical systems.
- Identify risks, delays, or compliance gaps and escalate with clear impact assessment and recommendations and proactively drive resolution in collaboration with study teams.
- Share best practices and lessons learned to improve overall GTAC performance and consistency.
- Resolve complex operational and documentation issues requiring cross‑functional coordination.
- Own accuracy and real‑time updates of GTAC operational trackers for assigned studies and countries.
- Provide clear and accurate operational and compliance updates to stakeholders and leadership.
- Ensure training compliance and adherence to training requirements as per Role Based Curriculum.
- Contribute to process improvement initiatives, standardization efforts, and adoption of tools or automation.
Qualifications & Experience
- Minimum of a bachelor’s degree in legal, Life science, Business Administration, or equivalent experience. Advanced degree a plus.
- Minimum 3-5 years of relevant clinical development & operational experience in Pharmaceutical, biotech, CRO or similar fields, is required.
- Seasoned field monitor with min 3+ years of global site monitoring (Clinical Research Associate) report review experience is preferred.
- Prior therapeutic area expertise (eg: Oncology, Cardiology, Hematology, Immunology etc) is preferred.
- Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies; including formulating responses to queries.
- Hands-on experience of preparing, reviewing, and submitting clinical study start-up / activation documentation, including responses to queries.
- Knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma, Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals.
- Effective communication skills in English (written & oral), computer skills - MS office suite, SharePoint, etc. CTMS (Veeva Vault experience preferred, knowledge of portals, databases and other Clinical Trial enabling technologies
- Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate.
- Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure.
- Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts.
- Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner.
- Ability to sustain high levels of performance in a constantly changing environment.
If you come across a role that intrigues you but does not 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™,” 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 an inclusive culture, promoting diversity 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
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 [email protected] . Visit careers.bms.com/ eeo -accessibility 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
How 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 https://careers.bms.com/ways-of-working.
Supporting People with Disabilities
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 [email protected] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
For roles based in Los Angeles County only: 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: https://careers.bms.com/california-residents/
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
If this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.
R1604884 : Global Trial Acceleration Associate