Clinical Trial Support Specialist
Brief Summary:
The position involves close collaboration with global clinical development teams while ensuring compliance with ICH-GCP guidelines, SOPs, and regulatory requirements.
Job Description:
Hereβs the LinkedIn-ready post in your preferred copy-paste format with CKEditor-compatible bold labels:
π WEβRE HIRING | Clinical Trial Support Specialist | Bristol Myers Squibb (BMS) | Hyderabad π
Are you passionate about Clinical Research, Clinical Operations, Clinical Trial Documentation, and Global Drug Development? π§ͺππ
π’ Bristol Myers Squibb (BMS) is hiring a Clinical Trial Support Specialist in Hyderabad to support global clinical development programs and contribute to life-changing healthcare innovations.
This is an excellent opportunity for professionals interested in Clinical Trial Operations, TMF Management, CTMS Administration, Regulatory Documentation, Submission Support, and Clinical Research Coordination.
If youβre looking to build a rewarding career in clinical research while working with one of the worldβs leading biopharmaceutical companies, this opportunity could be the perfect next step.
π’ Company: Bristol Myers Squibb (BMS)
π Website: https://www.bms.com
π Role: Clinical Trial Support Specialist
π’ Department: Clinical Operations / Clinical Trial Support
π Location: Hyderabad, Telangana, India
πΌ Job Type: Full-Time
π Work Model: Site-by-Design (Hybrid Eligible)
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π§ Key Responsibilities
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β Prepare clinical trial submission documents according to regulatory requirements
β Support Submission Managers in developing submission-ready clinical documentation
β Manage Clinical Study Report (CSR) appendices and financial disclosure documentation
β Ensure documents meet Submission Ready Compliance (SRC) standards
β Coordinate clinical trial site number creation for ongoing and new studies
β Maintain site milestones and regulatory approval information within clinical systems
β Manage investigational product shipment addresses and SAP-related data entry
β Perform reconciliation activities between Veeva eTMF and CTMS systems
β Support Trial Master File quality and inspection readiness
β Identify operational risks and implement mitigation strategies
β Ensure compliance with ICH-GCP guidelines, SOPs, and regulatory requirements
β Collaborate with cross-functional global clinical development teams
β Support oncology and other clinical trial portfolios with operational documentation activities
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π Required Qualifications
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π Educational Qualification
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Bachelorβs or Masterβs Degree in:
β’ Pharmacy
β’ Life Sciences
β’ Biotechnology
β’ Clinical Research
β’ Related Healthcare Disciplines
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β Preferred Qualifications
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β Understanding of Clinical Trial Processes and Drug Development Lifecycle
β Knowledge of ICH-GCP Guidelines and Regulatory Requirements
β Familiarity with TMF, eTMF, CTMS, and Clinical Documentation Processes
β Experience with Veeva Systems
β Strong Project Management and Organizational Skills
β Excellent Communication and Stakeholder Management Abilities
β Ability to Manage Multiple Priorities in a Fast-Paced Environment
β Strong Analytical and Problem-Solving Skills
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β¨ Why Join Bristol Myers Squibb?
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β¨ Exposure to Global Clinical Development Programs
β¨ Opportunity to Work with Leading Oncology Research Teams
β¨ Career Growth within Clinical Operations and Drug Development
β¨ Competitive Compensation and Benefits
β¨ Flexible and Collaborative Work Culture
β¨ Learning and Development Opportunities
β¨ Diverse and Inclusive Workplace Environment
β¨ Opportunity to Contribute to Innovative Medicines for Serious Diseases
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π Career Growth Opportunities
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This role can serve as a pathway to advanced positions such as:
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Clinical Trial Associate (CTA)
β
Clinical Operations Specialist
β
TMF Specialist
β
Clinical Project Coordinator
β
Study Start-Up Specialist
β
Clinical Trial Manager
β
Clinical Project Manager
β
Regulatory Operations Specialist
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π’ About Bristol Myers Squibb
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Bristol Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
With a strong focus on scientific innovation, clinical excellence, and patient outcomes, BMS continues to lead advancements across oncology, hematology, immunology, cardiovascular diseases, and other therapeutic areas.
π Core Focus Areas:
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Clinical Development
β
Oncology Research
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Drug Discovery & Development
β
Clinical Operations
β
Regulatory Excellence
β
Global Healthcare Innovation
β
Patient-Centric Solutions
Interested and eligible candidates can apply through the official Bristol Myers Squibb careers
π¬ Join WhatsApp Group:
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β‘ If youβre looking to build a successful career in Clinical Research, Clinical Operations, TMF Management, and Global Clinical Development, Bristol Myers Squibb offers an exceptional opportunity to work on impactful clinical programs while growing with a world-class biopharmaceutical organization.
Required Skills:
About Bristol Myers Squibb
With a strong focus on scientific innovation, clinical excellence, and patient outcomes, BMS continues to lead advancements across oncology, hematology, immunology, cardiovascular diseases, and other therapeutic areas.
- Website: https://www.bms.com