Senior manager, Clinical Scientist
Bristol-Myers Squibb
Senior manager, Clinical Scientist
Job Description
The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. 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 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 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.) Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). MD-Pharmacology preferred Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations 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) Detail-oriented with commitment to quality Basic knowledge of disease area, compound, current clinical landscape Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees 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., Pt Profiles, report generating tools)
About the Role/Company
- The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs
Key Responsibilities
- 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
- 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
- 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)
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Preferred Qualifications
- MD-Pharmacology
- Basic knowledge of disease area, compound, current clinical landscape
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Skills Required
- 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)
- 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., Pt Profiles, report generating tools)
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
1,500,000 - 3,000,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to understand assigned protocol(s) and their requirementsintermediate
- Basic knowledge skills to support program-specific data review and trend identificationintermediate
- Intermediate medical writing skills and medical terminologyintermediate
- Basic planning/project management skills (develop short range plans that are realistic and effective)intermediate
- 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/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)intermediate
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field) (experience)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations (experience)
Preferred Qualifications
- MD-Pharmacology (experience)
- Basic knowledge of disease area, compound, current clinical landscape (experience)
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees (experience)
Responsibilities
- 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
- 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
- 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)
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Answer 10 quick questions to check your fit for Senior manager, Clinical Scientist @ Bristol-Myers Squibb.
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Senior manager, Clinical Scientist
Bristol-Myers Squibb
Senior manager, Clinical Scientist
Job Description
The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. 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 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 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.) Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). MD-Pharmacology preferred Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations 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) Detail-oriented with commitment to quality Basic knowledge of disease area, compound, current clinical landscape Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees 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., Pt Profiles, report generating tools)
About the Role/Company
- The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs
Key Responsibilities
- 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
- 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
- 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)
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
Preferred Qualifications
- MD-Pharmacology
- Basic knowledge of disease area, compound, current clinical landscape
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
Skills Required
- 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)
- 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., Pt Profiles, report generating tools)
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
1,500,000 - 3,000,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to understand assigned protocol(s) and their requirementsintermediate
- Basic knowledge skills to support program-specific data review and trend identificationintermediate
- Intermediate medical writing skills and medical terminologyintermediate
- Basic planning/project management skills (develop short range plans that are realistic and effective)intermediate
- 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/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)intermediate
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field) (experience)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations (experience)
Preferred Qualifications
- MD-Pharmacology (experience)
- Basic knowledge of disease area, compound, current clinical landscape (experience)
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees (experience)
Responsibilities
- 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
- 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
- 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)
Tags & Categories
Answer 10 quick questions to check your fit for Senior manager, Clinical Scientist @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs