Job Title: Global Trial Acceleration Associate
Company: Bristol Myers Squibb (BMS)
Location: Hyderabad, Telangana, India
Job Type: Full-time
Occupancy Type: Site-essential / Hybrid / Field-based (based on role)
Role Summary:
The Global Trial Acceleration Associate manages and executes centralized activities supporting global clinical trials, with a focus on clinical documentation, start-up, and site activation. The role serves as a key point of contact for document management, ethical and regulatory submissions, and study-related activities, collaborating with internal and external stakeholders to ensure smooth clinical trial operations.
Key Responsibilities:
Manage and execute centralized trial activities across study phases (start-up, maintenance, close-out).
Interact with clinical study sites, CROs/vendors, Country Trial Managers (CTM/CTMo), and internal study teams.
Manage essential document collection, review, and approval for clinical trials.
Initiate and manage start-up documentation activities for global trials.
Support outsourcing activities, including selection, contracting, and execution of outsourced studies, ensuring compliance with BMS policies and regulatory standards.
Submit potential investigators for CTSS debarment review and track decisions.
Responsible for country/site activation, including final review and sign-off of activation checklists.
Provide quality control for start-up activities and maintain documentation in clinical systems (CTMS, eTMF, or vendor systems).
Arrange certified translation of study documentation as needed (e.g., ICF, Protocol, IB).
Coordinate creation of study-specific materials such as pharmacy or Investigator Site Files.
Assist with CSR distribution and country/site-level ICF adaptation.
Review site monitoring visit reports, escalate issues, and follow up on resolution.
Other duties assigned to support clinical trials.
Qualifications & Experience:
Minimum Bachelor’s degree in Life Sciences, Legal, Business Administration, or equivalent; advanced degree is a plus.
Minimum 3 years of relevant clinical development & operational experience in Pharmaceutical, Biotech, CRO, or related fields.
Preferred: 3+ years of global site monitoring (CRA) and report review experience.
Prior therapeutic area expertise preferred (e.g., Oncology, Cardiology, Hematology, Immunology).
Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRBs/IECs and Regulatory Agencies.
Knowledge of ICH-GCP, regulatory guidelines, and drug development processes.
Skills & Competencies:
Strong organizational, time-management, analytical, and decision-making skills.
Effective verbal and written communication skills in English.
Proficiency in MS Office Suite, SharePoint; familiarity with CTMS systems (Veeva Vault preferred).
Experience managing cross-functional, multi-cultural teams and influencing in a matrix structure.
Ability to manage multiple priorities, adapt to changing environments, and sustain high performance.
Collaborative, detail-oriented, and capable of problem-solving in ambiguous situations.
Work Environment & Additional Information:
On-site, hybrid, or field-based work depending on role requirements.
Travel as required for site visits or business needs.
BMS is committed to diversity, inclusion, and providing reasonable accommodations.
Employees are encouraged to maintain Covid-19 vaccination and boosters.
Compliance with local laws regarding qualified applicants with arrest or conviction records.
Contact for Accommodations: adastaffingsupport@bms.com
Reference: careers.bms.com/eeo-accessibility
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