PHARMAFull-time
Clinical Trial Support Specialist
HYDERABAD (IN)ONSITEPOSTED: 9/30/2026
PHARMAFull-time
HIRING ORGANIZATIONBRISTOL MYERS SQUIBBPharmaceuticals
BR
ROLE OVERVIEW
Support end-to-end clinical trial submission operations by preparing submission-ready documents, maintaining clinical trial systems and data, coordinating regulatory milestones, and enabling efficient clinical development activities across the oncology portfolio.
ROLE DEFINITION & RESPONSIBILITIES
- •Prepare Clinical Trial Submission documents in accordance with regulatory guidelines and BMS requirements
- •Partner with Submission Managers to coordinate timing and preparation of submission documents including CSR appendices and Financial Disclosure Tables
- •Ensure documents are appropriately formatted and Submission Ready Compliant
- •Create site numbers for new and ongoing clinical trials in collaboration with outsourced partners
- •Enter site milestones and regulatory approval dates to maintain accurate trial data
- •Verify drug shipment addresses and ensure accurate data feeds to SAP for clinical supply
- •Reconcile Veeva eTMF and CTMS data to maintain accurate clinical trial information
- •Analyze operational issues and develop mitigation and resolution strategies
- •Apply BMS SOPs, ICH/GCP, and regulatory requirements to submission deliverables
- •Support cross-functional and multicultural teams across the oncology portfolio
- •Manage document-management activities and support clinical-trial projects and initiatives
Reporting Hierarchy: Reports to or works in partnership with the Clinical Trial Submission/Operations leadership and Submission Manager; Exact reporting line and team size are not specified in the source posting
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in Life Sciences
- Approximately 4 years of pharmaceutical or biotechnology experience in a clinical drug development setting, including at least 2 years in pharmaceutical, biotech, or CRO environment
- Knowledge of ICH/GCP and regulatory guidelines
- Understanding of the global drug-development process
- Experience with Clinical Trial Master File systems or equivalent
- Strong organizational, time-management, analytical, decision-making, and communication skills
- Ability to work independently and within a matrix environment
PREFERRED QUALIFICATIONS
- •Advanced degree
- •Experience with Veeva Vault Clinical, eTMF, or CTMS
- •Experience with SharePoint, portals, databases, and clinical-trial enabling technologies
- •Experience supporting oncology clinical trials
- •Strong knowledge of protocol-management documentation and Core Template requirements
- •Experience with process improvement and complex issue resolution
REQUIRED VERIFIED SKILLS
Clinical trial support
Clinical trial submissions
ICH-GCP
Regulatory guidelines
Clinical Trial Master File
Veeva Vault
eTMF
CTMS
Clinical documentation
Submission-ready compliance
Protocol management
Regulatory milestones
Clinical trial operations
Document management
Project management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Comprehensive benefits; wellbeing and flexibility support; workplace accommodations; professional growth opportunities
The source posting does not disclose a salary range or bonus/equity amount. Compensation figures have therefore not been inferred.
ORGANIZATION CONTEXT & CULTURE
Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines for serious diseases. The company emphasizes patient impact, collaboration, accountability, inclusion, wellbeing, and professional growth.
TEAM SIZE: 30,000+ employees
INDUSTRY: Pharmaceuticals
Culture: BMS describes a purpose-driven, collaborative, inclusive, flexible, and patient-focused working environment with emphasis on innovation, accountability, wellbeing, and career development.
EXPECTED CAREER ROADMAP
The role can provide progression into senior clinical trial support, clinical trial operations, submission management, clinical project management, regulatory operations, or broader clinical development operations roles. Experience with Veeva systems, submission documents, GCP, regulatory requirements, and cross-functional oncology programs can support progression into specialized clinical operations positions.
APPLICATION ADVISORY
Highlight experience in pharmaceutical, biotech, CRO, or clinical drug development environments; emphasize ICH-GCP and regulatory knowledge; demonstrate hands-on experience with eTMF, CTMS, Veeva Vault, or comparable clinical-trial systems; highlight document preparation, submission coordination, data reconciliation, and milestone tracking; provide examples of managing multiple priorities and resolving complex operational issues in a matrix environment.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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