Instagram
youtube
Facebook

Senior Global Trial Acceleration Associate

3-5 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: Senior Global Trial Acceleration Associate

📍 Location: Hyderabad, Telangana, India
🕒 Employment Type: Full Time
🏢 Company: Bristol Myers Squibb (BMS)


🧭 Position Overview

The Senior Global Trial Acceleration Associate manages and executes centralized activities in support of global clinical trials, with a focus on clinical documentation, regulatory submissions, and site start-up/activation. The role interacts with clinical study sites, IRB/IECs, CROs/vendors, Country Trial Managers (CTMs), and other study team members.


⚙️ Key Responsibilities

Clinical Documentation & Trial Support

  • Serve as the primary contact for essential document management and ethical/regulatory submissions.

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

  • Review and submit regulatory documents, resolving issues with study sites.

  • Manage site/country activation processes, including document review, sign-off, and submission to Regulatory.

  • Conduct ongoing maintenance and tracking of essential documentation and submissions to Regulatory.

  • Manage correspondence with investigative sites (IB updates, protocol amendments).

  • Support Central/Local IRB/IEC processes, including submissions, approvals, and tracking.

  • Ensure proper collection and review of Financial Disclosure Forms.

  • Assist with creation/management of standardized document templates and CSR distribution.

  • Adapt and amend Informed Consent (IC) documents at country/site level.

Stakeholder & Vendor Management

  • Interact with study teams, clinical sites, IRB/IECs, CROs, vendors, and cross-functional teams.

  • Support outsourcing activities, including selection, contracting, and execution of studies.

  • Build collaborative relationships with clinical investigator sites and internal stakeholders.

Systems & Process Management

  • Update and review clinical systems (CTMS, eTMF, SharePoint).

  • Review/quality control of eTMF and other study documentation.

  • Arrange certified translation of study documents as needed.

  • Assist with coordination/creation of study-specific materials (e.g., pharmacy or investigator site files).


🎓 Qualifications & Experience

Education

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

Experience

  • 3–5 years of clinical development and operational experience in Pharmaceutical, Biotech, CRO, or related fields.

  • Hands-on experience preparing, reviewing, and submitting regulatory and clinical start-up documentation.

  • Knowledge of ICH/GCP and regulatory guidelines.

  • Experience with clinical study start-up, activation, and responses to queries.

Skills & Competencies

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

  • Effective written and oral communication skills in English.

  • Computer skills: MS Office Suite, SharePoint; CTMS (Veeva Vault preferred).

  • Ability to manage internal and external stakeholders across cross-functional, multi-cultural teams.

  • High adaptability and flexibility in ambiguous or complex environments.


🌍 Work Environment & Culture

  • BMS promotes challenging, meaningful, and life-changing work.

  • Employees are empowered to contribute within a supportive culture emphasizing: 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.

  • Data in recruitment is processed according to privacy policies.