Sr. Manager, TMF Process Lead
Bristol-Myers Squibb
Sr. Manager, TMF Process Lead
Job Description
Provides leadership within the TMF governance structure, acting as Subject Matter Expert for process groups and within cross-functional teams. Supports process optimization, continuous improvement, and quality governance for active studies. Represents TMF Process and eTMF Operations at meetings and leadership panels. Bachelor's degree in a related field, such as life sciences, computer science, or business administration. Minimum of 5 years of experience in clinical development operations, with a focus on eTMF. Preference to experience with project management methodologies and tools. Thorough understanding of ALCOA+ standards, Good Clinical Practice and Good Documentation practices and ICH guidelines, and applicable local regulatory requirements. Must have a strong understanding of the primary clinical business systems utilized for TMF process. Extensive knowledge of clinical trial documentation and TMF Management activities, including a strong technical understanding of Vault eTMF system. Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management systems. Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management. Demonstrated ability to create/provide TMF related training and coaching to a broad range of stakeholders. Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats. Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives. Strong analytical and problem-solving skills, with the ability to identify and resolve complex issues. Ability to work independently and manage multiple priorities in a fast-paced environment. Develops training materials, templates, job aids, plans, etc for TMF and archival processes. Provides training, support, and coaching for eTMF Operations Analysts, TMF Study Leads, Archive Leads, and Specialists (including CRO/FSP teams), on TMF processes and operating models. Process Development & Documentation Develops, updates, and maintains Procedural Documents, SOPs, Work Instructions, etc for TMF and archival processes and operations. Implements technical enhancements to eTMF, including innovation and automation, for improved quality and compliance oversight. Collaborates and consults multifunctionally to promote and support business and regulatory compliance and to identify opportunities to increase process and control efficiency. Provides technical leadership for eTMF operations and archival systems (e.g., Vault Clinical/Veeva CTMS/eTMF). Develops and monitors KPIs and metrics for TMF and archival compliance. Leads and participates in continuous improvement initiatives related to TMF management, archival and compliance. Addresses process compliance and performance gaps, as highlighted by quality metrics and KPIs. Leads and participates in TMF audits and inspection activities (readiness, preparedness, and management).
Key Responsibilities
- Provide leadership within the TMF governance structure
- Act as Subject Matter Expert for process groups and within cross-functional teams
- Support process optimization, continuous improvement, and quality governance for active studies
- Represent TMF Process and eTMF Operations at meetings and leadership panels
- Develop training materials, templates, job aids, plans, etc. for TMF and archival processes
- Provide training, support, and coaching for eTMF Operations Analysts, TMF Study Leads, Archive Leads, and Specialists on TMF processes and operating models
- Develop, update, and maintain Procedural Documents, SOPs, Work Instructions, etc. for TMF and archival processes and operations
- Implement technical enhancements to eTMF, including innovation and automation, for improved quality and compliance oversight
- Collaborate and consult multifunctionally to promote and support business and regulatory compliance and identify opportunities to increase process and control efficiency
- Provide technical leadership for eTMF operations and archival systems
- Develop and monitor KPIs and metrics for TMF and archival compliance
- Lead and participate in continuous improvement initiatives related to TMF management, archival, and compliance
- Address process compliance and performance gaps as highlighted by quality metrics and KPIs
- Lead and participate in TMF audits and inspection activities including readiness, preparedness, and management
Required Qualifications
- Bachelor's degree in a related field such as life sciences, computer science, or business administration
- Minimum of 5 years of experience in clinical development operations with a focus on eTMF
Preferred Qualifications
- Experience with project management methodologies and tools
Skills Required
- Thorough understanding of ALCOA+ standards, Good Clinical Practice, Good Documentation practices, ICH guidelines, and applicable local regulatory requirements
- Strong understanding of the primary clinical business systems utilized for TMF process
- Extensive knowledge of clinical trial documentation and TMF Management activities
- Strong technical understanding of Vault eTMF system
- Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management systems
- Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management
- Demonstrated ability to create/provide TMF related training and coaching to a broad range of stakeholders
- Excellent teamwork, interpersonal, and communication skills
- Ability to communicate and collaborate with employees and management at all levels and through various formats
- Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams
- Ability to influence areas not under direct control to achieve objectives
- Strong analytical and problem-solving skills
- Ability to identify and resolve complex issues
- Ability to work independently and manage multiple priorities in a fast-paced environment
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
1,500,000 - 2,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Thorough understanding of ALCOA+ standards, Good Clinical Practice, Good Documentation practices, ICH guidelines, and applicable local regulatory requirementsintermediate
- Strong understanding of the primary clinical business systems utilized for TMF processintermediate
- Extensive knowledge of clinical trial documentation and TMF Management activitiesintermediate
- Strong technical understanding of Vault eTMF systemintermediate
- Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management systemsintermediate
- Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Managementintermediate
- Demonstrated ability to create/provide TMF related training and coaching to a broad range of stakeholdersintermediate
- Excellent teamwork, interpersonal, and communication skillsintermediate
- Ability to communicate and collaborate with employees and management at all levels and through various formatsintermediate
- Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teamsintermediate
- Ability to influence areas not under direct control to achieve objectivesintermediate
- Strong analytical and problem-solving skillsintermediate
- Ability to identify and resolve complex issuesintermediate
- Ability to work independently and manage multiple priorities in a fast-paced environmentintermediate
Required Qualifications
- Bachelor's degree in a related field such as life sciences, computer science, or business administration (experience)
- Minimum of 5 years of experience in clinical development operations with a focus on eTMF (experience)
Preferred Qualifications
- Experience with project management methodologies and tools (experience)
Responsibilities
- Provide leadership within the TMF governance structure
- Act as Subject Matter Expert for process groups and within cross-functional teams
- Support process optimization, continuous improvement, and quality governance for active studies
- Represent TMF Process and eTMF Operations at meetings and leadership panels
- Develop training materials, templates, job aids, plans, etc. for TMF and archival processes
- Provide training, support, and coaching for eTMF Operations Analysts, TMF Study Leads, Archive Leads, and Specialists on TMF processes and operating models
- Develop, update, and maintain Procedural Documents, SOPs, Work Instructions, etc. for TMF and archival processes and operations
- Implement technical enhancements to eTMF, including innovation and automation, for improved quality and compliance oversight
- Collaborate and consult multifunctionally to promote and support business and regulatory compliance and identify opportunities to increase process and control efficiency
- Provide technical leadership for eTMF operations and archival systems
- Develop and monitor KPIs and metrics for TMF and archival compliance
- Lead and participate in continuous improvement initiatives related to TMF management, archival, and compliance
- Address process compliance and performance gaps as highlighted by quality metrics and KPIs
- Lead and participate in TMF audits and inspection activities including readiness, preparedness, and management
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Sr. Manager, TMF Process Lead
Bristol-Myers Squibb
Sr. Manager, TMF Process Lead
Job Description
Provides leadership within the TMF governance structure, acting as Subject Matter Expert for process groups and within cross-functional teams. Supports process optimization, continuous improvement, and quality governance for active studies. Represents TMF Process and eTMF Operations at meetings and leadership panels. Bachelor's degree in a related field, such as life sciences, computer science, or business administration. Minimum of 5 years of experience in clinical development operations, with a focus on eTMF. Preference to experience with project management methodologies and tools. Thorough understanding of ALCOA+ standards, Good Clinical Practice and Good Documentation practices and ICH guidelines, and applicable local regulatory requirements. Must have a strong understanding of the primary clinical business systems utilized for TMF process. Extensive knowledge of clinical trial documentation and TMF Management activities, including a strong technical understanding of Vault eTMF system. Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management systems. Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management. Demonstrated ability to create/provide TMF related training and coaching to a broad range of stakeholders. Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats. Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives. Strong analytical and problem-solving skills, with the ability to identify and resolve complex issues. Ability to work independently and manage multiple priorities in a fast-paced environment. Develops training materials, templates, job aids, plans, etc for TMF and archival processes. Provides training, support, and coaching for eTMF Operations Analysts, TMF Study Leads, Archive Leads, and Specialists (including CRO/FSP teams), on TMF processes and operating models. Process Development & Documentation Develops, updates, and maintains Procedural Documents, SOPs, Work Instructions, etc for TMF and archival processes and operations. Implements technical enhancements to eTMF, including innovation and automation, for improved quality and compliance oversight. Collaborates and consults multifunctionally to promote and support business and regulatory compliance and to identify opportunities to increase process and control efficiency. Provides technical leadership for eTMF operations and archival systems (e.g., Vault Clinical/Veeva CTMS/eTMF). Develops and monitors KPIs and metrics for TMF and archival compliance. Leads and participates in continuous improvement initiatives related to TMF management, archival and compliance. Addresses process compliance and performance gaps, as highlighted by quality metrics and KPIs. Leads and participates in TMF audits and inspection activities (readiness, preparedness, and management).
Key Responsibilities
- Provide leadership within the TMF governance structure
- Act as Subject Matter Expert for process groups and within cross-functional teams
- Support process optimization, continuous improvement, and quality governance for active studies
- Represent TMF Process and eTMF Operations at meetings and leadership panels
- Develop training materials, templates, job aids, plans, etc. for TMF and archival processes
- Provide training, support, and coaching for eTMF Operations Analysts, TMF Study Leads, Archive Leads, and Specialists on TMF processes and operating models
- Develop, update, and maintain Procedural Documents, SOPs, Work Instructions, etc. for TMF and archival processes and operations
- Implement technical enhancements to eTMF, including innovation and automation, for improved quality and compliance oversight
- Collaborate and consult multifunctionally to promote and support business and regulatory compliance and identify opportunities to increase process and control efficiency
- Provide technical leadership for eTMF operations and archival systems
- Develop and monitor KPIs and metrics for TMF and archival compliance
- Lead and participate in continuous improvement initiatives related to TMF management, archival, and compliance
- Address process compliance and performance gaps as highlighted by quality metrics and KPIs
- Lead and participate in TMF audits and inspection activities including readiness, preparedness, and management
Required Qualifications
- Bachelor's degree in a related field such as life sciences, computer science, or business administration
- Minimum of 5 years of experience in clinical development operations with a focus on eTMF
Preferred Qualifications
- Experience with project management methodologies and tools
Skills Required
- Thorough understanding of ALCOA+ standards, Good Clinical Practice, Good Documentation practices, ICH guidelines, and applicable local regulatory requirements
- Strong understanding of the primary clinical business systems utilized for TMF process
- Extensive knowledge of clinical trial documentation and TMF Management activities
- Strong technical understanding of Vault eTMF system
- Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management systems
- Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management
- Demonstrated ability to create/provide TMF related training and coaching to a broad range of stakeholders
- Excellent teamwork, interpersonal, and communication skills
- Ability to communicate and collaborate with employees and management at all levels and through various formats
- Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams
- Ability to influence areas not under direct control to achieve objectives
- Strong analytical and problem-solving skills
- Ability to identify and resolve complex issues
- Ability to work independently and manage multiple priorities in a fast-paced environment
Locations
- Hyderabad TS, India
Salary
Estimated Salary Rangemedium confidence
1,500,000 - 2,500,000 INR / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Thorough understanding of ALCOA+ standards, Good Clinical Practice, Good Documentation practices, ICH guidelines, and applicable local regulatory requirementsintermediate
- Strong understanding of the primary clinical business systems utilized for TMF processintermediate
- Extensive knowledge of clinical trial documentation and TMF Management activitiesintermediate
- Strong technical understanding of Vault eTMF systemintermediate
- Strong working knowledge of TMF and technical knowledge of Vault eTMF and clinical document management systemsintermediate
- Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Managementintermediate
- Demonstrated ability to create/provide TMF related training and coaching to a broad range of stakeholdersintermediate
- Excellent teamwork, interpersonal, and communication skillsintermediate
- Ability to communicate and collaborate with employees and management at all levels and through various formatsintermediate
- Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teamsintermediate
- Ability to influence areas not under direct control to achieve objectivesintermediate
- Strong analytical and problem-solving skillsintermediate
- Ability to identify and resolve complex issuesintermediate
- Ability to work independently and manage multiple priorities in a fast-paced environmentintermediate
Required Qualifications
- Bachelor's degree in a related field such as life sciences, computer science, or business administration (experience)
- Minimum of 5 years of experience in clinical development operations with a focus on eTMF (experience)
Preferred Qualifications
- Experience with project management methodologies and tools (experience)
Responsibilities
- Provide leadership within the TMF governance structure
- Act as Subject Matter Expert for process groups and within cross-functional teams
- Support process optimization, continuous improvement, and quality governance for active studies
- Represent TMF Process and eTMF Operations at meetings and leadership panels
- Develop training materials, templates, job aids, plans, etc. for TMF and archival processes
- Provide training, support, and coaching for eTMF Operations Analysts, TMF Study Leads, Archive Leads, and Specialists on TMF processes and operating models
- Develop, update, and maintain Procedural Documents, SOPs, Work Instructions, etc. for TMF and archival processes and operations
- Implement technical enhancements to eTMF, including innovation and automation, for improved quality and compliance oversight
- Collaborate and consult multifunctionally to promote and support business and regulatory compliance and identify opportunities to increase process and control efficiency
- Provide technical leadership for eTMF operations and archival systems
- Develop and monitor KPIs and metrics for TMF and archival compliance
- Lead and participate in continuous improvement initiatives related to TMF management, archival, and compliance
- Address process compliance and performance gaps as highlighted by quality metrics and KPIs
- Lead and participate in TMF audits and inspection activities including readiness, preparedness, and management
Tags & Categories
Answer 10 quick questions to check your fit for Sr. Manager, TMF Process Lead @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs