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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
🕒 Employment Type: Full Time
🏢 Company: Bristol Myers Squibb (BMS)


🧭 Position Overview

The Global Trial Acceleration Associate manages and executes centralized activities to support global clinical trials, focusing 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 study teams, supporting all study phases: start-up, maintenance, and close-out.


⚙️ Key Responsibilities

Clinical Documentation & Trial Support

  • Act as main contact for essential document management, ethical/regulatory submissions, and study documentation.

  • Initiate and manage start-up documentation for global clinical trials.

  • Submit potential investigators to CTSS for debarment review and track decisions.

  • Manage country/site activation, including document review, checklist sign-off, and site activation.

  • Provide quality control support for start-up activities.

  • Maintain and track essential documentation throughout the study lifecycle.

  • Ongoing communication with study teams regarding centralized trial activities.

  • Arrange certified translation of study documentation (ICF, Protocol, IB) as required.

  • 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.

  • Create/manage standardized document templates as needed.

  • Perform other duties to support clinical trials.

Stakeholder & Vendor Management

  • Collaborate with internal and external stakeholders including CROs, vendors, CTMs, CTMos, and study teams.

  • Support outsourcing activities: selection, contracting, and execution of outsourced studies while ensuring compliance with regulatory standards, ethical practices, and BMS policies.

Systems & Process Management

  • Update and review clinical systems (CTMS, eTMF, SharePoint) to report trial document status.

  • Perform quality control of study documentation and eTMF.


🎓 Qualifications & Experience

Education

  • Bachelor’s degree in Life Sciences, Legal, Business Administration, or equivalent; advanced degree preferred.

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 experience.

  • Hands-on experience preparing, reviewing, and submitting regulatory documentation to IRB/IECs and Regulatory Agencies.

  • Experience in clinical study start-up/activation documentation and handling queries.

  • Knowledge of ICH/GCP and regulatory guidelines/directives.

  • Prior therapeutic area expertise (Oncology, Cardiology, Hematology, Immunology, etc.) preferred.

Skills & Competencies

  • Strong organizational, time-management, analytical, and decision-making skills.

  • Effective oral and written communication in English.

  • Proficiency in MS Office Suite, SharePoint, CTMS (Veeva Vault preferred), and other clinical trial enabling technologies.

  • Experience managing key internal and external stakeholders and cross-functional, multi-cultural teams.

  • Ability to manage multiple priorities, adapt to change, and sustain high performance in dynamic environments.


🌍 Work Environment & Culture

  • BMS promotes a supportive culture empowering employees to apply individual talents to clinical trial participation 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 as 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 strongly encouraged to maintain up-to-date COVID-19 vaccinations.

  • Recruitment data is processed according to privacy policies.