🏷️ Job Title: Global Trial Acceleration Associate
📍 Location: Hyderabad, Telangana, India
🏢 Company: Bristol Myers Squibb (BMS)
🕒 Employment Type: Full-time
🧭 Position Overview
The Global Trial Acceleration Associate is responsible for managing and executing centralized activities supporting global clinical trials, with a focus on clinical documentation, regulatory submissions, and site start-up/activation. The role interacts with clinical study sites, CROs/vendors, Country Trial Managers (CTM)/Clinical Trial Monitors (CTMo), and cross-functional teams to support all trial phases: start-up, maintenance, and close-out.
⚙️ Key Responsibilities
Clinical Documentation & Trial Support
Act as primary contact for essential document management, ethical/regulatory submissions, and study documentation.
Initiate, manage, and maintain start-up documentation for global clinical trials.
Submit potential investigators for CTSS debarment review and track decisions.
Manage country/site activation, including final document review and checklist sign-off.
Perform quality control of start-up activities and documentation.
Maintain and track essential trial documentation throughout all study phases.
Arrange certified translation of study documentation (ICF, Protocol, IB) as needed.
Assist in coordination/creation of study-specific materials (e.g., pharmacy files, investigator site files).
Support CSR distribution and country/site-level ICF adaptation.
Collect, review, and approve country and site-level documents.
Centrally review Site Monitoring Visit reports, escalate issues, and track resolution.
Develop and manage standardized document templates.
Communicate ongoing centralized study activities with study teams.
Perform other duties to support clinical trials as assigned.
Stakeholder & Vendor Management
Collaborate with internal/external stakeholders including CROs, vendors, CTMs, CTMos, and study teams.
Support outsourcing activities: selection, contracting, and execution of outsourced studies in compliance with regulations and BMS policies.
Systems & Process Management
Update and review clinical systems (CTMS, eTMF, SharePoint) to track clinical trial document status.
Conduct quality control of study documentation and resolve eTMF-related issues.
🎓 Qualifications & Experience
Education
Bachelor’s degree in Life Sciences, Legal, Business Administration, or equivalent.
Advanced degree is a plus.
Experience
Minimum 3 years in clinical development and operational experience in pharmaceutical, biotech, CRO, or related fields.
Preferably experienced as a field monitor (Clinical Research Associate) with global site monitoring report review.
Prior therapeutic area expertise (Oncology, Cardiology, Hematology, Immunology, etc.) preferred.
Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies.
Knowledge of ICH/GCP and regulatory guidelines/directives.
Skills & Competencies
Strong organizational, time-management, analytical, and decision-making skills.
Effective communication skills (written and oral) in English.
Proficient in MS Office Suite, SharePoint, CTMS (Veeva Vault preferred), and other clinical trial enabling technologies.
Proven ability to manage internal/external stakeholders and cross-functional teams.
High adaptability to dynamic work environments and multiple priorities.
🌍 Work Environment & Culture
BMS promotes a supportive culture empowering employees to apply individual talents to clinical trials and patient outcomes.
Core values: Passion, Innovation, Urgency, Accountability, Inclusion, Integrity.
🏢 On-site Protocol
Site-essential: 100% onsite
Site-by-design: Hybrid (≥50% onsite)
Field-based/Remote-by-design: Travel required for meetings, customers, and patients
⚖️ Equal Employment & Safety
BMS provides accommodations for people with disabilities.
Applicants with arrest or conviction records are considered per local laws.
Employees are encouraged to maintain up-to-date COVID-19 vaccinations.
Recruitment data is processed according to applicable privacy policies.
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Frank Scottile Blvd |Missouri :
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