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Clinical Scientist, Cell Therapy
Company | Bristol Myers Squibb |
Address | Summit, NJ, United States |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-06-08 |
Posted at | 1 year ago |
Working with Us
- May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
- May lead or support trial level activities for one or more trials with the necessary supervision
- 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
- 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.)
- Conduct literature review
- Review clinical narratives
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Develop Data Review Plan in collaboration with Data Management
- Monitor clinical data for specific trends
- Seek out and enact best practices with instruction
- Provide regular and timely updates to manager/management as requested
- Submit clinical documents to TMF
- Develop site and CRA training materials and present these at SIVs and Investigator meetings
- Collaborate and liaise with external partners (e.g., KOLs)
- Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Intermediate medical writing skills and medical terminology
- Basic knowledge skills to support program-specific data review and trend identification
- Basic planning/project management skills (develop short range plans that are realistic and effective)
- Ability to understand assigned protocol(s) and their requirements
- Detail-oriented with commitment to quality
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
- Basic knowledge of disease area, compound, current clinical landscape
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Intermediate critical thinking and problem-solving skills
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