Global biopharmaceutical leader Bristol Myers Squibb (BMS) has announced a new opportunity for the position of Clinical Trial Support Specialist in Hyderabad, India. This exciting clinical research and clinical operations role offers professionals the opportunity to contribute to global drug development programs while supporting critical clinical trial documentation, submissions, site management, and regulatory compliance activities.
Candidates interested in clinical trial operations, TMF management, CTMS administration, submission support, and clinical research coordination are encouraged to apply for this full-time opportunity at Bristol Myers Squibb.
Job Overview
- Job Title: Clinical Trial Support Specialist
- Company: Bristol Myers Squibb (BMS)
- Location: Hyderabad, Telangana, India
- Job Type: Full-Time
- Job Requisition ID: R1602784
- Department: Clinical Operations / Clinical Trial Support
- Work Model: Site-by-Design (Hybrid Eligible)
Key Responsibilities
The Clinical Trial Support Specialist will support clinical development programs by ensuring accurate preparation, management, and maintenance of clinical trial documentation and operational systems.
Key responsibilities include:
- Preparing clinical trial submission documents according to regulatory requirements.
- Supporting Submission Managers in developing submission-ready clinical documentation.
- Managing Clinical Study Report (CSR) appendices and financial disclosure documentation.
- Ensuring documents meet Submission Ready Compliance (SRC) standards.
- Coordinating clinical trial site number creation for ongoing and new studies.
- Maintaining site milestones and regulatory approval information within clinical systems.
- Managing investigational product shipment addresses and SAP-related data entry.
- Performing reconciliation activities between Veeva eTMF and CTMS systems.
- Supporting trial master file quality and inspection readiness.
- Identifying operational risks and implementing mitigation strategies.
- Ensuring compliance with ICH-GCP guidelines, SOPs, and regulatory requirements.
- Collaborating with cross-functional global clinical development teams.
- Supporting oncology and other clinical trial portfolios with operational documentation activities.
Required Qualifications
Candidates with experience or educational backgrounds related to life sciences, pharmacy, biotechnology, clinical research, or healthcare may be suitable for this role.
Preferred qualifications include:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Clinical Research, or related disciplines.
- Understanding of clinical trial processes and drug development lifecycle.
- Knowledge of ICH-GCP guidelines and regulatory requirements.
- Familiarity with Trial Master File (TMF), eTMF, CTMS, and clinical documentation processes.
- Experience with Veeva systems is advantageous.
- Strong project management and organizational skills.
- Excellent communication and stakeholder management abilities.
- Ability to manage multiple priorities in a fast-paced clinical operations environment.
- Strong analytical and problem-solving capabilities.
Essential Skills
Clinical Trial Support Specialist candidates should possess:
- Clinical Operations Support
- Clinical Trial Documentation Management
- TMF and eTMF Management
- CTMS Administration
- Regulatory Submission Support
- Veeva Systems Knowledge
- Clinical Study Report Documentation
- Trial Master File Reconciliation
- ICH-GCP Compliance
- Quality and Inspection Readiness
- Clinical Research Coordination
- SAP Data Management
- Project Management
- Cross-functional Collaboration
- Regulatory Affairs Support
Why Join Bristol Myers Squibb?
Bristol Myers Squibb is recognized globally for its commitment to advancing innovative medicines for serious diseases. Employees benefit from:
- Exposure to global clinical development programs.
- Opportunities to work with leading oncology research teams.
- Career growth within clinical operations and drug development.
- Competitive compensation and benefits.
- Flexible and collaborative work culture.
- Learning and development opportunities.
- Diverse and inclusive workplace environment.
Career Growth Opportunities
This Clinical Trial Support Specialist position can serve as a pathway to advanced roles such as:
- Clinical Trial Associate (CTA)
- Clinical Operations Specialist
- TMF Specialist
- Clinical Project Coordinator
- Study Start-Up Specialist
- Clinical Trial Manager
- Clinical Project Manager
- Regulatory Operations Specialist
How to Apply
