Global biopharma leader Bristol Myers Squibb (BMS) is inviting applications for the role of Clinical Trial Support Specialist in Hyderabad. This is a great opportunity for professionals interested in clinical research, clinical operations, and global drug development programs.
The role focuses on supporting clinical trials through documentation, submission processes, TMF management, and regulatory compliance, making it ideal for candidates aiming to grow in clinical research and operations.
Job Overview
- Job Title: Clinical Trial Support Specialist
- Company: Bristol Myers Squibb (BMS)
- Location: Hyderabad, Telangana, India
- Job Type: Full-Time
- Requisition ID: R1602784
- Department: Clinical Operations
- Work Model: Hybrid (Site-by-Design)
Key Responsibilities
- Prepare clinical trial submission documents as per regulatory requirements
- Support submission managers with documentation readiness
- Manage Clinical Study Report (CSR) appendices and disclosures
- Ensure compliance with Submission Ready Compliance (SRC) standards
- Maintain clinical trial site data and milestones in systems
- Handle investigational product logistics and SAP entries
- Perform reconciliation between Veeva eTMF and CTMS systems
- Maintain Trial Master File (TMF) quality and inspection readiness
- Identify operational risks and implement mitigation strategies
- Ensure compliance with ICH-GCP guidelines and SOPs
- Collaborate with global clinical teamsRequired Qualifications
- Bachelor’s or Master’s degree in:
- Pharmacy (B.Pharm / M.Pharm / Pharm.D)
- Life Sciences
- Biotechnology
- Clinical Research
- Or related fields
- Knowledge of:
- Clinical trial lifecycle
- ICH-GCP guidelines
- Regulatory submission processes
- TMF, eTMF, CTMS systems
- Additional Skills:
- Strong documentation & organizational skills
- Analytical thinking & problem-solving
- Communication & stakeholder management
Preferred Skills
- Clinical operations support
- TMF & eTMF management
- CTMS administration
- Regulatory submission coordination
- Veeva system experience
- Clinical data & SAP handling
- Project management skills
Why Join Bristol Myers Squibb?
- Work on global clinical trials and drug development programs
- Exposure to oncology and advanced research pipelines
- Strong career growth in clinical operations
- Competitive salary and benefits
- Flexible and collaborative work culture
- Inclusive and diverse workplace
Career Growth Opportunities
This role can lead to:
- Clinical Trial Associate (CTA)
- Clinical Operations Specialist
- TMF Specialist
- Clinical Project Coordinator
- Clinical Trial Manager
- Regulatory Operations Specialist
Who Should Apply?
This opportunity is ideal for:
- Pharmacy graduates (B.Pharm, M.Pharm, Pharm.D)
- Life Sciences & Biotechnology candidates
- Clinical Research professionals
- Regulatory and documentation specialists
- Candidates looking to enter clinical operations
How to Apply
Interested candidates can apply through the official Bristol Myers Squibb careers portal:
👉 Visit: BMS Careers Website
(Search using Requisition ID: R1602784)
Frequently Asked Questions (FAQs) BMS
1. What is the location of this job?
The job is based in Hyderabad, India.
2. Is this role suitable for freshers?
Candidates with basic knowledge of clinical trials may apply, but experience is preferred.
3. What systems knowledge is required?
Familiarity with TMF, eTMF, CTMS, and Veeva systems is beneficial.
4. What is the work model?
This is a hybrid role (Site-by-Design model).
5. What career growth can I expect?
You can progress to roles like CTA, Clinical Project Manager, or Regulatory Operations Specialist.
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