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Global Trial Acceleration Associate

3+ years
Not Disclosed
10 Nov. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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