Job Title: Senior Global Trial Specialist
Location: Hyderabad, TS, India
Company: Bristol Myers Squibb
Division: Research and Development
Position Summary
The Senior Global Trial Specialist (SGTS) contributes to the operational execution of clinical studies, ensuring timely, high-quality delivery in compliance with ICH/GCP, regulatory guidelines, and company SOPs. The SGTS collaborates with cross-functional global teams to support all operational aspects of clinical research studies from protocol development to final clinical study report.
Key Responsibilities
Project Management:
Serve as a subject matter expert (SME) in operational processes for study startup, maintenance, and closeout.
Utilize performance metrics and quality indicators to support Global Trial Managers in study execution.
Identify potential risks and implement proactive mitigation strategies.
Resolve routine problems independently and escalate critical issues appropriately.
Collaborate effectively with cross-functional teams.
Study/Project Planning, Conduct, and Management:
Provide input on study-level tools and plans with moderate to minimal supervision.
Perform core Global Trial Specialist tasks independently while escalating issues as needed.
Contribute to study meetings and lead relevant discussions.
Oversee country regulatory approvals (CTA, MoH) and IRB/IEC approvals/notifications.
Manage vendor and site payment processing and tracking.
Maintain study budget tracking tools and reconcile invoices with contracts and finance reports.
Qualifications & Experience
Educational Requirements:
Bachelor’s or Master’s degree in a relevant discipline (e.g., Life Sciences, Pharmacy, Clinical Research).
Experience Requirements:
Minimum 1 year of experience in Clinical Research or a related field.
Familiarity with Clinical Trial Management Systems (CTMS) and Trial Master File (TMF) systems.
Global clinical research experience is required.
Technical Competencies:
Strong knowledge of ICH/GCP, regulatory guidelines, and clinical trial processes.
Experience in clinical research budgets, site and vendor payment tracking (preferred).
Basic project management knowledge (preferred).
Management & Leadership Competencies:
Build and maintain strong relationships with key stakeholders.
Adapt to changing business demands and proactively seek improvement opportunities.
Support and mentor junior team members.
Communicate effectively across cross-functional teams.
Additional Information
Travel Requirements:
Less than 5% travel expected.
Work Model:
Hybrid work model (minimum 50% onsite presence required for site-by-design roles).
Field-based and remote-by-design roles require occasional travel for business meetings and site visits.
Why Join Bristol Myers Squibb?
At Bristol Myers Squibb, every employee plays an integral role in transforming patients’ lives through science. We foster an inclusive, diverse, and innovative work environment where employees can grow and thrive. We also offer competitive benefits, flexibility, and career development opportunities.
Diversity & Inclusion Commitment:
We are committed to equal employment opportunities and encourage individuals with disabilities to apply. Reasonable workplace accommodations/adjustments can be requested as needed.
COVID-19 Policy:
BMS strongly recommends employees be fully vaccinated and up to date with COVID-19 boosters.
How to Apply:
Interested candidates can visit careers.bms.com to apply.
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