Bristol Myers Squibb (BMS) is inviting applications for the position of eTMF Specialist at its Hyderabad, Telangana location. The opportunity is within clinical trial operations, focusing on electronic Trial Master File (eTMF) management, clinical documentation quality, regulatory document review, and inspection readiness.
The selected candidate will support global clinical trials by managing essential study documents, performing quality reviews, maintaining accurate documentation records, and coordinating with clinical study teams to ensure document completeness and compliance with ALCOA Plus principles.
Job Details
| Particulars | Details |
|---|---|
| Company | Bristol Myers Squibb (BMS) |
| Job Title | eTMF Specialist |
| Job Location | Hyderabad, Telangana |
| Job Type | Full Time |
| Job Requisition ID | R1608032 |
| Posted | Today |
| Functional Area | Clinical Trials / Document Management |
Number of Positions
Applications are invited for the eTMF Specialist position under requisition ID R1608032.
Roles and Responsibilities
Selected candidates will be responsible for:
- Managing centralized activities supporting global clinical trials, with a focus on clinical documentation.
- Uploading electronic documents into the eTMF system and performing rigorous quality reviews.
- Ensuring clinical documents are inspection-ready and compliant with ALCOA Plus principles.
- Applying appropriate filing attributes and metadata to support document classification, identification, management, and retrieval.
- Providing immediate feedback on document quality issues.
- Coordinating with regional teams, study teams, and cross-functional departments to maintain document quality, timeliness, and completeness.
- Supporting clinical studies throughout start-up, maintenance, and close-out phases.
- Reviewing essential regulatory documentation and submitting final documents to the eTMF.
- Providing quality control support for clinical study start-up activities.
- Acting as the single point of contact for centralized document management activities.
- Maintaining and tracking essential records and collecting updated or outstanding documentation.
- Proactively resolving issues related to missing or expired documents.
- Maintaining regular communication with clinical study teams regarding document management activities.
Eligibility and Qualifications
Bristol Myers Squibb emphasizes skills and capabilities and encourages candidates to apply even if their experience or credentials do not perfectly match the role.
Required Skills and Knowledge
The role involves the following areas of expertise:
- Electronic Trial Master File (eTMF) Management
- Clinical Documentation Management
- ALCOA Plus Principles
- Document Quality Review
- Regulatory Documentation
- Document Filing and Metadata Management
- Clinical Trial Documentation
- Inspection Readiness
- Essential Records Management
- Document Tracking and Reconciliation
- Clinical Study Start-up and Close-out Support
- Cross-functional Coordination
- Document Quality Control
Application Details
Interested candidates can apply through the official Bristol Myers Squibb careers portal.
- Company: Bristol Myers Squibb
- Position: eTMF Specialist
- Location: Hyderabad, Telangana
- Requisition ID: R1608032
