Senior Global Trial Acceleration Associate – Clinical Operations
Location: Hyderabad, Telangana, India
Experience Required: 3–5 Years
Job Type: Full-Time
Job ID: R1593804
About Bristol Myers Squibb (BMS)
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader committed to transforming patients’ lives through science™. With a focus on oncology, immunology, cardiovascular, and other therapeutic areas, BMS delivers innovative therapies and clinical solutions worldwide. BMS fosters a culture of collaboration, inclusion, and innovation, providing employees with opportunities for professional growth while driving impact across the healthcare ecosystem.
Position Overview
The Senior Global Trial Acceleration Associate plays a key role in centralized clinical trial support, ensuring efficient execution of global studies with a strong emphasis on documentation, regulatory compliance, and ethical oversight. The role interacts with clinical sites, IRBs/IECs, CROs/vendors, and cross-functional teams to streamline study start-up, conduct, and close-out activities.
This position serves as a primary point of contact for document management, regulatory submissions, site activation, and coordination of global trial processes, ensuring adherence to BMS and regulatory standards.
Key Responsibilities
Global Trial Execution & Documentation
Lead centralized clinical trial activities, including document management and ethical/regulatory submissions.
Coordinate start-up documentation: feasibility questionnaires, site debarment checks, and regulatory submissions to eTMF.
Oversee country/site activation including final review and sign-off of checklists.
Ensure accurate maintenance, tracking, and quality control of essential study documents in CTMS, eTMF, and other platforms.
Site & Stakeholder Coordination
Serve as the main liaison for study teams, clinical sites, and IRBs/IECs.
Support site-facing activities, including Informed Consent adaptation/amendments and clinical query resolution.
Manage correspondence with investigative sites (e.g., protocol amendments, IB updates) and facilitate IRB/IEC approvals.
Operational & Compliance Support
Support outsourced study activities, interfacing with vendors, operational teams, and service providers.
Ensure compliance with regulatory standards, GCP/ICH guidelines, BMS outsourcing, and procurement policies.
Assist in creation and management of standardized document templates and CSR distribution.
Continuous Process Improvement
Maintain effective communication with cross-functional teams regarding centralized study activities.
Ensure ongoing monitoring of Financial Disclosure Forms, safety submissions, and site documentation.
Contribute to process optimization, quality improvements, and study efficiency initiatives.
Required Qualifications & Skills
Education: Bachelor’s degree in Life Sciences, Legal, Business Administration, or related field. Advanced degree is a plus.
Experience: 3–5 years in clinical development, clinical operations, or pharmaceutical/CRO environments.
Technical Expertise: Hands-on experience with regulatory submissions, site activation documentation, CTMS (Veeva Vault preferred), eTMF, and other clinical trial systems.
Regulatory Knowledge: Strong understanding of GCP/ICH guidelines, regulatory standards, and drug development processes.
Communication & Collaboration: Excellent English verbal and written communication skills; proven ability to work with cross-functional, multi-cultural teams.
Analytical & Organizational Skills: Strong time management, decision-making, and organizational abilities to manage multiple priorities effectively.
Adaptability: Ability to perform in a dynamic, complex environment while maintaining high performance and professionalism.
Why Join BMS
Contribute to global clinical trials that advance life-changing therapies.
Work within a collaborative, inclusive, and high-performing culture.
Access career development, cross-functional exposure, and professional growth opportunities.
Engage with innovative technologies and global clinical processes across multiple therapeutic areas.
Equal Opportunity & Accessibility
BMS is committed to diversity, equity, and inclusion. Applicants with disabilities may request reasonable accommodations during the recruitment process. The application process is secure and transparent; BMS will never request payments or financial information.
Apply Now to join a team accelerating global clinical trials and transforming patient outcomes.
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