Sr. Global Trial Acceleration Associate

Bristol Myers Squibb; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Bristol Myers Squibb in Hyderabad seeks a Senior Global Trial Acceleration Associate to drive centralized clinical operations across global studies within the GTAC. You will execute start-up, regulatory submissions, and site activities with limited supervision, ensuring timely, inspection-ready outputs.

The role requires cross-functional collaboration, strong regulatory knowledge, and effective stakeholder management to keep timelines, quality, and compliance on track in a dynamic, globally

Qualifications

• Bachelor’s degree in legal, Life science, Business Administration, or equivalent experience.
• Advanced degree is a plus.
• 5–8 years of clinical development & operational experience in pharma, biotech, CRO or similar fields.

Responsibilities

• Manage centralized clinical trial start-up and regulatory activities across studies/countries.
• Prepare and coordinate CTP submissions to EC/IEC per regulations.
• Maintain On-site Investigator Files (OSIF) and ensure SOP compliance.
• Support EU-CTR submissions and regulatory timelines.

Skills

Clinical operations

Regulatory submissions

ICH/GCP knowledge

Stakeholder management

Cross-functional collaboration

Problem solving

English communication

Education

Bachelor's degree (legal, Life science, Business Admin or equivalent)

Advanced degree

Tools

Veeva Vault

CTMS

MS Office

SharePoint

Job description

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 Senior Global Trial Acceleration Associate plays an expanded role in delivering centralized clinical operations activities within the Global Trial Acceleration Center (GTAC). This role supports the acceleration of clinical trial start‑up, regulatory, and site operational activities through independent execution, enhanced problem‑solving, and proactive coordination across global studies.

This position operates with increased autonomy and accountability compared to the base GTAA role and supports moderately complex studies and countries. The role requires effective cross‑functional and cross‑cultural collaboration and consistent delivery of high‑quality, inspection‑ready outputs.

Key Responsibilities

• Independently manage and execute centralized clinical trial start‑up and regulatory activities across assigned studies and countries with limited supervision.
• Prepare, collect, review, and coordinate approval of clinical trial package (CTP) in accordance with project plans, SOPs, Work Instructions, and applicable global and local regulations.
• Manage country and site‑level Informed Consent Form (ICF) adaptations, coordinating with sites and stakeholders to ensure alignment with protocol, regulatory, and Ethics Committee requirements.
• Prepare and compile study submission dossiers for Ethics Committees (EC/IEC), including initial submissions and amendments, and coordinate responses to EC queries.
• Prepare and maintain On‑site Investigator Files (OSIF) and ensure completeness and quality in line with applicable SOPs and inspection standards.
• Support regulatory and start‑up timelines by identifying potential delays and coordinating timely resolution with internal and external stakeholders.
• Process and manage site‑level financial activities, including site invoices and payments, in alignment with executed Clinical Trial Agreements (CTA) and applicable systems.
• Create, update, and close purchase orders (PO) for sites, IRBs, and Health Authorities in accordance with defined processes and approvals.
• Coordinate procurement and delivery of study and site insurance from BMS‑approved vendors as per study requirements.
• Support study feasibility and site selection activities, including investigator debarment checks and documentation support.
• Provide operational support for Patient Engagement and Recruitment (PER) activities, including coordination with study teams and vendors as required.
• Support EU-CTR submissions as per applicable SOP and Work instructions.
• Manage Subject‑Related Injury (SRI) reimbursement activities, escalating complex cases appropriately.
• Ensure adherence to applicable SOPs, Work Instructions, GCP, timelines, and GTAC KPIs across all assigned activities.
• Maintain accurate, complete, and inspection‑ready documentation within CTMS, eTMF, and other clinical systems.
• Identify operational or compliance risks and elevate with a clear summary of issue, impact, and proposed next steps.
• Support audit and inspection readiness activities, including document verification and response coordination where required.
• Collaborate effectively across functions (Clinical Operations, Regulatory, Legal, Finance, and Vendors) to support study objectives.
• Share process learnings and best practices within the GTAC team to promote consistency and efficiency.
• Provide guidance or peer support to junior team members or new joiners, as appropriate.
• Contribute to process improvement initiatives, standardization efforts, or tool enhancements led by GTAC leadership.
• Own the accuracy and timeliness of GTAC operational trackers for assigned studies and countries.
• Provide clear and timely status updates on deliverables, risks, and progress to study and GTAC stakeholders.
• Ensure completion of role‑based training and ongoing compliance with training requirement.

Qualifications & Experience

• Minimum of a bachelor’s degree in legal, Life science, Business Administration, or equivalent experience. Advanced degree a plus.
• 5-8 years of relevant clinical development & operational experience in Pharmaceutical, biotech, CRO or similar fields, is required.
• 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.

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 [e-mail]. 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.

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 [e-mail]. 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.

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 [e-mail] 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.

R1606963 : Sr. Global Trial Acceleration Associate