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Senior Global Trial Acceleration Associate

Bristol Myers Squibb
Bristol Myers Squibb
3-5 years
Not Disclosed
10 March 14, 2026
Job Description
Job Type: Full Time Education: B.Com/ BBA/ MBA/ M.Com/ B.Sc/ M.Sc/ B.Tech/ M.Tech/ BE/ ME and All Graduats Skills:

Job Description

Position Summary
The Senior Global Trial Acceleration Associate is responsible for managing centralized operational activities that support global clinical trials, with a strong focus on clinical documentation and regulatory processes. The role ensures that study start-up, maintenance, and close-out activities are executed efficiently while maintaining compliance with regulatory and ethical requirements.

This position collaborates with clinical study sites, regulatory authorities, CROs, and internal study teams to manage documentation, regulatory submissions, and essential trial processes throughout the clinical trial lifecycle.

Key Responsibilities

Manage and execute centralized operational activities supporting global clinical trials

Coordinate with study sites, CROs, vendors, and internal teams throughout study start-up, maintenance, and close-out phases

Initiate and manage study start-up documentation including feasibility questionnaires, investigator submissions, and regulatory documentation

Review essential regulatory documents and resolve outstanding issues with investigative sites

Submit final regulatory documents to the electronic Trial Master File (eTMF)

Support country and site activation activities including document review, activation checklists, and regulatory submission coordination

Maintain and track clinical trial documentation using clinical systems such as CTMS and eTMF

Coordinate translation of study documentation including informed consent forms, protocols, and investigator brochures

Act as a central point of contact for the study team for trial start-up and centralized operational activities

Manage communication with investigative sites related to protocol amendments, investigator brochure updates, and regulatory approvals

Support IRB/IEC submissions and approval tracking for safety reports and study documentation

Ensure completeness and quality control of eTMF documentation throughout the study lifecycle

Assist with creation of standardized document templates and study materials when required

Support preparation and distribution of clinical study reports (CSR)

Professional Experience Requirements

3–5 years of experience in clinical development, clinical trial operations, or related pharmaceutical or CRO environments

Hands-on experience with regulatory documentation and IRB/IEC submissions

Understanding of ICH-GCP guidelines and clinical trial regulatory requirements

Experience managing clinical trial documentation and start-up activities

Familiarity with clinical trial systems such as CTMS and eTMF (Veeva Vault preferred)

Strong organizational, communication, and stakeholder management skills

Ability to work effectively in cross-functional and global team environments

Apply Details

Apply via the company career portal for
Bristol Myers Squibb