Clinical Scientist
Bristol-Myers Squibb
Clinical Scientist
Job Description
Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct. Collaborate and liaise with external partners (e.g., KOLs). Seek out and enact best practices with instruction. Provide regular and timely updates to manager/management as requested. Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required. Conduct literature review. Develop site and CRA training materials and present these at SIVs and Investigator meetings. Review clinical narratives. Collaborate cross-functionally to monitor clinical data for specific trends. Contribute to the development of 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. Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.) Submit clinical documents to TMF. Supporting People with Disabilities Basic planning/project management skills (develop short range plans that are realistic and effective). Basic knowledge of disease area, compound, current clinical landscape. Detail-oriented with commitment to quality Intermediate critical thinking and problem-solving skills. 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 skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools). Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred). Expectation of 2+ years of experience in clinical science, clinical research, or equivalent. Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. Ability to understand assigned protocol(s) and their requirements. Knowledge and skills to support program-specific data review and trend identification. Intermediate medical writing skills and medical terminology. Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Key Responsibilities
- Design and execute assigned clinical trial activities
- Work closely with clinical team members to execute trial conduct activities
- Collaborate and liaise with external partners (e.g., KOLs)
- Seek out and enact best practices with instruction
- Provide regular and timely updates to manager/management as requested
- Collaborate cross-functionally to develop Protocol and ICF documents/amendments
- Present Protocol and ICF documents/amendments to governance committee and early clinical development team meetings
- Conduct literature review
- Develop site and CRA training materials
- Present training materials at SIVs and Investigator meetings
- Review clinical narratives
- Collaborate cross-functionally to monitor clinical data for specific trends
- Contribute to the development of Data Review Plan in collaboration with Data Management
- Ensure CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Author/review clinical contributions to clinical study reports (CSRs)
- Author/review clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses)
- Contribute to regulatory submission
- Submit clinical documents to TMF
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field)
- + years of experience in clinical science, clinical research, or equivalent
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Skills Required
- Basic planning/project management skills
- Basic knowledge of disease area, compound, current clinical landscape
- Detail-oriented with commitment to quality
- Intermediate critical thinking and problem-solving skills
- 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 skills in Microsoft Word/Excel/PowerPoint
- Intermediate skills in data review tools (e.g., patient profiles, report generating tools)
- Ability to understand assigned protocol(s) and their requirements
- Knowledge and skills to support program-specific data review and trend identification
- Intermediate medical writing skills and medical terminology
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Locations
- Warsaw, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
80,000 - 130,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Basic planning/project management skillsintermediate
- Basic knowledge of disease area, compound, current clinical landscapeintermediate
- Detail-oriented with commitment to qualityintermediate
- Intermediate critical thinking and problem-solving skillsintermediate
- 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
- Intermediate skills in Microsoft Word/Excel/PowerPointintermediate
- Intermediate skills in data review tools (e.g., patient profiles, report generating tools)intermediate
- Ability to understand assigned protocol(s) and their requirementsintermediate
- Knowledge and skills to support program-specific data review and trend identificationintermediate
- Intermediate medical writing skills and medical terminologyintermediate
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committeesintermediate
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) (experience)
- + years of experience in clinical science, clinical research, or equivalent (experience)
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations (experience)
Responsibilities
- Design and execute assigned clinical trial activities
- Work closely with clinical team members to execute trial conduct activities
- Collaborate and liaise with external partners (e.g., KOLs)
- Seek out and enact best practices with instruction
- Provide regular and timely updates to manager/management as requested
- Collaborate cross-functionally to develop Protocol and ICF documents/amendments
- Present Protocol and ICF documents/amendments to governance committee and early clinical development team meetings
- Conduct literature review
- Develop site and CRA training materials
- Present training materials at SIVs and Investigator meetings
- Review clinical narratives
- Collaborate cross-functionally to monitor clinical data for specific trends
- Contribute to the development of Data Review Plan in collaboration with Data Management
- Ensure CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Author/review clinical contributions to clinical study reports (CSRs)
- Author/review clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses)
- Contribute to regulatory submission
- Submit clinical documents to TMF
Tags & Categories
Clinical Scientist
Bristol-Myers Squibb
Clinical Scientist
Job Description
Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct. Collaborate and liaise with external partners (e.g., KOLs). Seek out and enact best practices with instruction. Provide regular and timely updates to manager/management as requested. Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required. Conduct literature review. Develop site and CRA training materials and present these at SIVs and Investigator meetings. Review clinical narratives. Collaborate cross-functionally to monitor clinical data for specific trends. Contribute to the development of 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. Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.) Submit clinical documents to TMF. Supporting People with Disabilities Basic planning/project management skills (develop short range plans that are realistic and effective). Basic knowledge of disease area, compound, current clinical landscape. Detail-oriented with commitment to quality Intermediate critical thinking and problem-solving skills. 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 skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools). Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred). Expectation of 2+ years of experience in clinical science, clinical research, or equivalent. Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. Ability to understand assigned protocol(s) and their requirements. Knowledge and skills to support program-specific data review and trend identification. Intermediate medical writing skills and medical terminology. Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Key Responsibilities
- Design and execute assigned clinical trial activities
- Work closely with clinical team members to execute trial conduct activities
- Collaborate and liaise with external partners (e.g., KOLs)
- Seek out and enact best practices with instruction
- Provide regular and timely updates to manager/management as requested
- Collaborate cross-functionally to develop Protocol and ICF documents/amendments
- Present Protocol and ICF documents/amendments to governance committee and early clinical development team meetings
- Conduct literature review
- Develop site and CRA training materials
- Present training materials at SIVs and Investigator meetings
- Review clinical narratives
- Collaborate cross-functionally to monitor clinical data for specific trends
- Contribute to the development of Data Review Plan in collaboration with Data Management
- Ensure CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Author/review clinical contributions to clinical study reports (CSRs)
- Author/review clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses)
- Contribute to regulatory submission
- Submit clinical documents to TMF
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field)
- + years of experience in clinical science, clinical research, or equivalent
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Skills Required
- Basic planning/project management skills
- Basic knowledge of disease area, compound, current clinical landscape
- Detail-oriented with commitment to quality
- Intermediate critical thinking and problem-solving skills
- 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 skills in Microsoft Word/Excel/PowerPoint
- Intermediate skills in data review tools (e.g., patient profiles, report generating tools)
- Ability to understand assigned protocol(s) and their requirements
- Knowledge and skills to support program-specific data review and trend identification
- Intermediate medical writing skills and medical terminology
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Locations
- Warsaw, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
80,000 - 130,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Basic planning/project management skillsintermediate
- Basic knowledge of disease area, compound, current clinical landscapeintermediate
- Detail-oriented with commitment to qualityintermediate
- Intermediate critical thinking and problem-solving skillsintermediate
- 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
- Intermediate skills in Microsoft Word/Excel/PowerPointintermediate
- Intermediate skills in data review tools (e.g., patient profiles, report generating tools)intermediate
- Ability to understand assigned protocol(s) and their requirementsintermediate
- Knowledge and skills to support program-specific data review and trend identificationintermediate
- Intermediate medical writing skills and medical terminologyintermediate
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committeesintermediate
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) (experience)
- + years of experience in clinical science, clinical research, or equivalent (experience)
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations (experience)
Responsibilities
- Design and execute assigned clinical trial activities
- Work closely with clinical team members to execute trial conduct activities
- Collaborate and liaise with external partners (e.g., KOLs)
- Seek out and enact best practices with instruction
- Provide regular and timely updates to manager/management as requested
- Collaborate cross-functionally to develop Protocol and ICF documents/amendments
- Present Protocol and ICF documents/amendments to governance committee and early clinical development team meetings
- Conduct literature review
- Develop site and CRA training materials
- Present training materials at SIVs and Investigator meetings
- Review clinical narratives
- Collaborate cross-functionally to monitor clinical data for specific trends
- Contribute to the development of Data Review Plan in collaboration with Data Management
- Ensure CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Author/review clinical contributions to clinical study reports (CSRs)
- Author/review clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses)
- Contribute to regulatory submission
- Submit clinical documents to TMF
Tags & Categories