Head of RCO Monitoring Excellence and Support
Bristol-Myers Squibb
Head of RCO Monitoring Excellence and Support
Job Description
Develop and maintain global process, procedural documents, and training materials in compliance with GCP requirements and internal quality standards. Develop, implement, and manage monitoring strategies, including risk-based monitoring, study conduct, study oversight approaches, and methodology. Establish a center of excellence for monitoring, developing and disseminating best practices across the organization. Implement and oversee process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms including both product, clinical trial quality, system utilization and process effectiveness. Drive continuous improvement efforts through data-driven decision-making and collaboration with cross-functional stakeholders Maintain global expertise through external partnerships, ongoing training, and participation in industry forums. Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the SMEs for all risk-based monitoring, study conduct and study oversight approaches. Develop and implement a monitoring oversight strategy, inclusive of managing both internally and external vendor(s) to ensure quality and compliance with applicable policies and procedures as outlined in study-specific monitoring plans. Develop and implement strategies for business continuity in monitoring and clinical study/site management Maintain inspection readiness storyboards for Clinical Study and Site Management processes and support Health Authority Inspections. Supervise and coordinate the work assignments and performance of Monitoring Excellence and Support staff to ensure timely execution consistent with R&D research goals and priorities. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. A minimum of 10 years pharmaceutical industry experience in Clinical Research or Medical Affairs Significant monitoring experience required. Experience in the planning, conduct and management of clinical programs (Phase I-IV) Demonstrated ability to drive project related activities. Previous experience leading, managing, coaching, and developing direct reports In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs In depth knowledge and understanding of clinical research processes, regulations, and methodology. Ability to manage and lead complex regional and/or global initiatives. Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management. Demonstrated organizational and planning skills and independent decision-making ability. Strong organization and time management skills and ability to effectively manage multiple competing priorities. Outstanding interpersonal, oral, and written communication skills to influence, inform or guide others.
Key Responsibilities
- Develop and maintain global process, procedural documents, and training materials in compliance with GCP requirements and internal quality standards
- Develop, implement, and manage monitoring strategies, including risk-based monitoring, study conduct, study oversight approaches, and methodology
- Establish a center of excellence for monitoring, developing and disseminating best practices across the organization
- Implement and oversee process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms for product, clinical trial quality, system utilization, and process effectiveness
- Drive continuous improvement efforts through data-driven decision-making and collaboration with cross-functional stakeholders
- Maintain global expertise through external partnerships, ongoing training, and participation in industry forums
- Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the SMEs for all risk-based monitoring, study conduct, and study oversight approaches
- Develop and implement a monitoring oversight strategy, managing both internal and external vendors to ensure quality and compliance with applicable policies and procedures as outlined in study-specific monitoring plans
- Develop and implement strategies for business continuity in monitoring and clinical study/site management
- Maintain inspection readiness storyboards for Clinical Study and Site Management processes and support Health Authority Inspections
- Supervise and coordinate the work assignments and performance of Monitoring Excellence and Support staff to ensure timely execution consistent with R&D research goals and priorities
Required Qualifications
- A minimum of 10 years pharmaceutical industry experience in Clinical Research or Medical Affairs
- Significant monitoring experience
- Experience in the planning, conduct, and management of clinical programs (Phase I-IV)
- Previous experience leading, managing, coaching, and developing direct reports
- In-depth understanding of GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs
- In-depth knowledge and understanding of clinical research processes, regulations, and methodology
Skills Required
- Demonstrated ability to drive project-related activities
- Ability to manage and lead complex regional and/or global initiatives
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
- Demonstrated organizational and planning skills and independent decision-making ability
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Outstanding interpersonal, oral, and written communication skills to influence, inform, or guide others
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Field United States, United States
- Field Switzerland, Switzerland
Salary
Estimated Salary Rangemedium confidence
150,000 - 250,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated ability to drive project-related activitiesintermediate
- Ability to manage and lead complex regional and/or global initiativesintermediate
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records managementintermediate
- Demonstrated organizational and planning skills and independent decision-making abilityintermediate
- Strong organization and time management skills and ability to effectively manage multiple competing prioritiesintermediate
- Outstanding interpersonal, oral, and written communication skills to influence, inform, or guide othersintermediate
Required Qualifications
- A minimum of 10 years pharmaceutical industry experience in Clinical Research or Medical Affairs (experience)
- Significant monitoring experience (experience)
- Experience in the planning, conduct, and management of clinical programs (Phase I-IV) (experience)
- Previous experience leading, managing, coaching, and developing direct reports (experience)
- In-depth understanding of GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs (experience)
- In-depth knowledge and understanding of clinical research processes, regulations, and methodology (experience)
Responsibilities
- Develop and maintain global process, procedural documents, and training materials in compliance with GCP requirements and internal quality standards
- Develop, implement, and manage monitoring strategies, including risk-based monitoring, study conduct, study oversight approaches, and methodology
- Establish a center of excellence for monitoring, developing and disseminating best practices across the organization
- Implement and oversee process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms for product, clinical trial quality, system utilization, and process effectiveness
- Drive continuous improvement efforts through data-driven decision-making and collaboration with cross-functional stakeholders
- Maintain global expertise through external partnerships, ongoing training, and participation in industry forums
- Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the SMEs for all risk-based monitoring, study conduct, and study oversight approaches
- Develop and implement a monitoring oversight strategy, managing both internal and external vendors to ensure quality and compliance with applicable policies and procedures as outlined in study-specific monitoring plans
- Develop and implement strategies for business continuity in monitoring and clinical study/site management
- Maintain inspection readiness storyboards for Clinical Study and Site Management processes and support Health Authority Inspections
- Supervise and coordinate the work assignments and performance of Monitoring Excellence and Support staff to ensure timely execution consistent with R&D research goals and priorities
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Answer 10 quick questions to check your fit for Head of RCO Monitoring Excellence and Support @ Bristol-Myers Squibb.
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Head of RCO Monitoring Excellence and Support
Bristol-Myers Squibb
Head of RCO Monitoring Excellence and Support
Job Description
Develop and maintain global process, procedural documents, and training materials in compliance with GCP requirements and internal quality standards. Develop, implement, and manage monitoring strategies, including risk-based monitoring, study conduct, study oversight approaches, and methodology. Establish a center of excellence for monitoring, developing and disseminating best practices across the organization. Implement and oversee process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms including both product, clinical trial quality, system utilization and process effectiveness. Drive continuous improvement efforts through data-driven decision-making and collaboration with cross-functional stakeholders Maintain global expertise through external partnerships, ongoing training, and participation in industry forums. Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the SMEs for all risk-based monitoring, study conduct and study oversight approaches. Develop and implement a monitoring oversight strategy, inclusive of managing both internally and external vendor(s) to ensure quality and compliance with applicable policies and procedures as outlined in study-specific monitoring plans. Develop and implement strategies for business continuity in monitoring and clinical study/site management Maintain inspection readiness storyboards for Clinical Study and Site Management processes and support Health Authority Inspections. Supervise and coordinate the work assignments and performance of Monitoring Excellence and Support staff to ensure timely execution consistent with R&D research goals and priorities. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. A minimum of 10 years pharmaceutical industry experience in Clinical Research or Medical Affairs Significant monitoring experience required. Experience in the planning, conduct and management of clinical programs (Phase I-IV) Demonstrated ability to drive project related activities. Previous experience leading, managing, coaching, and developing direct reports In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research and Medical Affairs In depth knowledge and understanding of clinical research processes, regulations, and methodology. Ability to manage and lead complex regional and/or global initiatives. Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management. Demonstrated organizational and planning skills and independent decision-making ability. Strong organization and time management skills and ability to effectively manage multiple competing priorities. Outstanding interpersonal, oral, and written communication skills to influence, inform or guide others.
Key Responsibilities
- Develop and maintain global process, procedural documents, and training materials in compliance with GCP requirements and internal quality standards
- Develop, implement, and manage monitoring strategies, including risk-based monitoring, study conduct, study oversight approaches, and methodology
- Establish a center of excellence for monitoring, developing and disseminating best practices across the organization
- Implement and oversee process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms for product, clinical trial quality, system utilization, and process effectiveness
- Drive continuous improvement efforts through data-driven decision-making and collaboration with cross-functional stakeholders
- Maintain global expertise through external partnerships, ongoing training, and participation in industry forums
- Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the SMEs for all risk-based monitoring, study conduct, and study oversight approaches
- Develop and implement a monitoring oversight strategy, managing both internal and external vendors to ensure quality and compliance with applicable policies and procedures as outlined in study-specific monitoring plans
- Develop and implement strategies for business continuity in monitoring and clinical study/site management
- Maintain inspection readiness storyboards for Clinical Study and Site Management processes and support Health Authority Inspections
- Supervise and coordinate the work assignments and performance of Monitoring Excellence and Support staff to ensure timely execution consistent with R&D research goals and priorities
Required Qualifications
- A minimum of 10 years pharmaceutical industry experience in Clinical Research or Medical Affairs
- Significant monitoring experience
- Experience in the planning, conduct, and management of clinical programs (Phase I-IV)
- Previous experience leading, managing, coaching, and developing direct reports
- In-depth understanding of GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs
- In-depth knowledge and understanding of clinical research processes, regulations, and methodology
Skills Required
- Demonstrated ability to drive project-related activities
- Ability to manage and lead complex regional and/or global initiatives
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
- Demonstrated organizational and planning skills and independent decision-making ability
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Outstanding interpersonal, oral, and written communication skills to influence, inform, or guide others
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Field United States, United States
- Field Switzerland, Switzerland
Salary
Estimated Salary Rangemedium confidence
150,000 - 250,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Demonstrated ability to drive project-related activitiesintermediate
- Ability to manage and lead complex regional and/or global initiativesintermediate
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records managementintermediate
- Demonstrated organizational and planning skills and independent decision-making abilityintermediate
- Strong organization and time management skills and ability to effectively manage multiple competing prioritiesintermediate
- Outstanding interpersonal, oral, and written communication skills to influence, inform, or guide othersintermediate
Required Qualifications
- A minimum of 10 years pharmaceutical industry experience in Clinical Research or Medical Affairs (experience)
- Significant monitoring experience (experience)
- Experience in the planning, conduct, and management of clinical programs (Phase I-IV) (experience)
- Previous experience leading, managing, coaching, and developing direct reports (experience)
- In-depth understanding of GCP, ICH Guidelines, and other local guidance, regulation, and codes of practice related to Clinical Research and Medical Affairs (experience)
- In-depth knowledge and understanding of clinical research processes, regulations, and methodology (experience)
Responsibilities
- Develop and maintain global process, procedural documents, and training materials in compliance with GCP requirements and internal quality standards
- Develop, implement, and manage monitoring strategies, including risk-based monitoring, study conduct, study oversight approaches, and methodology
- Establish a center of excellence for monitoring, developing and disseminating best practices across the organization
- Implement and oversee process monitoring methods, including data collection and analysis, metrics and associated targets, and reporting mechanisms for product, clinical trial quality, system utilization, and process effectiveness
- Drive continuous improvement efforts through data-driven decision-making and collaboration with cross-functional stakeholders
- Maintain global expertise through external partnerships, ongoing training, and participation in industry forums
- Develop, deploy, and manage a Monitoring Strategy and Execution team which serves as the SMEs for all risk-based monitoring, study conduct, and study oversight approaches
- Develop and implement a monitoring oversight strategy, managing both internal and external vendors to ensure quality and compliance with applicable policies and procedures as outlined in study-specific monitoring plans
- Develop and implement strategies for business continuity in monitoring and clinical study/site management
- Maintain inspection readiness storyboards for Clinical Study and Site Management processes and support Health Authority Inspections
- Supervise and coordinate the work assignments and performance of Monitoring Excellence and Support staff to ensure timely execution consistent with R&D research goals and priorities
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Head of RCO Monitoring Excellence and Support @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs