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 escalate with a explicit 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr. Global Trial Acceleration Associate (Hyderabad)
🏢 Bristol-Myers Squibb
📍 Hyderabad