The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
May serve as Clinical Trial Lead for one or more trials
May lead or support trial level activities for one or more trials with the necessary supervision
May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
Provides clinical, medical and scientific expertise to cross-functional BMS colleagues

Responsibilities:
Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
Conduct literature review
Submit clinical documents to TMF
Develop site and CRA training materials and present these at SIVs and Investigator meetings
Review clinical narratives
Medical monitoring of assigned clinical studies
Monitor clinical data for specific trends
Develop Data Review Plan in collaboration with Data Management




Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission).

Qualification and Experience requirements:
Medical qualification (MBBS, MD, DM)
Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Experience in Oncology TA
Ability to understand assigned protocol(s) and their requirements
Basic knowledge skills to support program-specific data review and trend identification
Intermediate medical writing skills and medical terminology
Basic planning/project management skills (develop short range plans that are realistic and effective)
Medical monitoring experience in Late phase clinical trials
Detail-oriented with commitment to quality

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Clinical Scientist Hoct Telangana (India)
🏢 Bristol-Myers Squibb
📍 India