🏷️ 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.
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Frank Scottile Blvd |Missouri :
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Queensland |Melbourne :
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