Clinical Trial Transparency and Submission Operations Roles
Bristol Myers Squibb (BMS) is seeking talented and dedicated individuals to join our Clinical Trial Transparency and Submission Operations team. These roles, based in Hyderabad, Telangana, India, offer the opportunity to contribute to our commitment to regulatory compliance, public disclosure, and patient-focused drug development. You will collaborate with cross-functional scientific, medical, and regulatory experts to ensure the integrity and transparency of our clinical trial data. We are currently hiring for three distinct positions: Clinical Trial Registration Sr. Specialist, Clinical Trial Disclosure Manager, and Clinical Trial Submission Document Specialist.
Job Summary
The Clinical Trial Transparency and Submission Operations team is responsible for ensuring the accurate and timely registration, disclosure, and submission of clinical trial information in accordance with global regulatory requirements. These roles are crucial in maintaining transparency and supporting patient-focused drug development initiatives.
Responsibilities
Specific responsibilities vary depending on the role. Below is a breakdown by position:
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Clinical Trial Registration Sr. Specialist:
- Manage clinical trial registrations on ClinicalTrials.gov, EU PAS, and other global registries.
- Coordinate with clinical, regulatory, and safety teams to ensure accurate and timely updates.
- Ensure compliance with NIH and other global guidelines.
- Maintain study trackers and educate teams on registry compliance requirements.
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Clinical Trial Disclosure Manager:
- Oversee redaction compliance under EMA Policy 0070, PRCI, and EU CTR.
- Ensure operational execution of disclosure deliverables, adhering to timelines and quality standards.
- Manage vendors and stakeholder communication related to clinical trial disclosure.
- Contribute to SOP improvements and support regulatory updates and cross-functional change management.
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Clinical Trial Submission Document Specialist:
- Support FDA submission deliverables, including CSR appendices, ensuring accuracy and completeness.
- Perform formatting checks and ensure submission readiness compliance.
- Collaborate with CTSS and other cross-functional teams to prepare documents for submission.
- Utilize platforms such as Veeva Vault, CTMS, SharePoint, and TMF systems.
Requirements
The ideal candidate will possess the following qualifications:
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Clinical Trial Registration Sr. Specialist:
- Bachelor’s degree in Science.
- Minimum 3 years of experience in the pharmaceutical or CRO industry.
- Knowledge of regulatory compliance, transparency, and clinical trial operations.
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Clinical Trial Disclosure Manager:
- Bachelor’s or Master’s degree in a scientific or medical domain.
- 6–8 years of experience, with 3–4 years specifically in transparency and disclosure.
- Strong understanding of global clinical trial disclosure policies (e.g., EMA Policy 0070, PRCI, EU CTR).
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Clinical Trial Submission Document Specialist:
- Bachelor’s degree in Life Sciences or Business.
- 1–4 years of experience in clinical documentation or a pharmaceutical environment.
- Knowledge of ICH-GCP, document management, and regulatory submission workflows.
Key Skills (Across Roles):
- Clinical trial operations
- Regulatory compliance (FDA, EMA, EU CTR, NIH)
- Familiarity with Veeva Vault, CTMS, and TMF systems (preferred)
- Project management and stakeholder communication
- Strong documentation, analytical, and organizational abilities
Benefits
BMS offers a comprehensive benefits package, including:
- Meaningful work that directly impacts patient lives
- Global exposure across diverse therapeutic areas
- Hybrid work flexibility for eligible roles
- Opportunities for learning and cross-functional growth
Location
These positions are located in Hyderabad, Telangana, India.
How to Apply
If you are a qualified and motivated individual seeking a challenging and rewarding opportunity, we encourage you to apply. Please visit the BMS careers website and search for the specific job title to submit your application.