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Senior Global Trial Acceleration Associate

3-5 years
Not Disclosed
10 Oct. 7, 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

ob Title: Senior Global Trial Acceleration Associate

Location: Hyderabad, Telangana, India
Company: Bristol Myers Squibb (BMS)


Company Overview

Bristol Myers Squibb (BMS) is a global biopharmaceutical company committed to transforming patients’ lives through science. BMS offers challenging, meaningful, and life-changing work across diverse therapeutic areas, promoting a culture of collaboration, inclusion, and innovation.


Job Overview

The Senior Global Trial Acceleration Associate manages and executes centralized activities supporting global clinical trials, focusing on clinical documentation, regulatory submissions, and site activation. This role interacts with clinical sites, IRBs/IECs, CROs, study teams, and other functional areas to ensure smooth trial start-up, maintenance, and close-out.


Key Responsibilities

Clinical Trial Start-Up & Documentation

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

  • Provide input on feasibility questionnaires and distribute/track responses.

  • Submit potential investigators to CTSS for debarment review.

  • Review essential regulatory documentation and resolve site issues.

  • Submit finalized documents to electronic Trial Master File (eTMF).

  • Activate sites/countries in compliance with study procedures.

  • Quality control of start-up activities as required.

Document Management & Regulatory Support

  • Maintain, update, and review study-related clinical systems (CTMS, eTMF).

  • Arrange certified translations of study documents.

  • Coordinate creation and management of study-specific materials (e.g., pharmacy files, ISF).

  • Serve as the single point of contact for centralized activities during study start-up.

  • Collect and track essential documentation; submit to Regulatory as needed.

  • Manage correspondence to investigative sites and coordinate IRB/IEC approvals.

  • Support submission of safety-related documents (SUSARs, DSURs, etc.).

  • Conduct QC of eTMF to ensure accuracy and completeness.

  • Lead or support global processes for Financial Disclosure Forms.

  • Assist with CSR distribution and informed consent adaptation/amendments.

Stakeholder Management & Collaboration

  • Build collaborative relationships with clinical investigator sites, study teams, CTM/CTMo., and vendors.

  • Interface with operational teams and service providers to ensure regulatory compliance and adherence to BMS policies.

  • Manage internal and external stakeholder communications effectively.

Other Responsibilities

  • Assist with creation/management of standardized document templates.

  • Perform additional duties as assigned to support clinical trials.


Qualifications & Experience

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

  • 3–5 years of relevant clinical development and operational experience in Pharmaceutical, Biotech, CRO, or similar industries.

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

  • Knowledge of ICH/GCP and regulatory guidelines; understanding of drug development processes.

  • Proficiency in MS Office Suite, SharePoint, and clinical trial management systems (CTMS, eTMF; Veeva Vault preferred).

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

  • Effective communication (written and oral) and ability to work in cross-functional, multi-cultural teams.

  • Proven ability to manage multiple priorities in a dynamic and evolving environment.


Work Environment & On-Site Requirements

  • May be site-essential, hybrid, field-based, or remote-by-design depending on role requirements.

  • Ability to travel to sites, customers, patients, or business partners as needed.


Equal Opportunity & Safety

  • BMS is committed to diversity, inclusion, and reasonable workplace accommodations.

  • Vaccination against Covid-19 is strongly recommended.

  • Employment is considered regardless of arrest/conviction records, in accordance with applicable law.