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Global Trial Acceleration Associate

3+ years
Not Disclosed
10 Oct. 4, 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

📍 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.