Sr. Manager, TMF System Business Lead
Bristol-Myers Squibb
Sr. Manager, TMF System Business Lead
Job Description
Provide subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance . Align with process owners to ensure utilization of our clinical business systems is conducted in accordance with established processes and procedures. Align within functional stakeholders to represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements. Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively. Provide final business, regulatory, and administrative approvals per applicable SOPs. Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users. Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads. Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews. Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities. Bachelor's degree in a related field, such as life sciences, computer science, or business administration. Minimum of 7+ years of experience in clinical development operations, with a focus on eTMF. Preference to experience with project management methodologies and tools. Must have a strong understanding of the primary clinical business systems utilized for TMF process. 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.
Key Responsibilities
- Provide subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance
- Align with process owners to ensure utilization of clinical business systems is conducted in accordance with established processes and procedures
- Represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements
- Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively
- Provide final business, regulatory, and administrative approvals per applicable SOPs
- Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users
- Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads
- Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews
- Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities
Required Qualifications
- Bachelor's degree in a related field such as life sciences, computer science, or business administration
- Minimum of 7+ years of experience in clinical development operations with a focus on eTMF
Preferred Qualifications
- Experience with project management methodologies and tools
Skills Required
- Strong understanding of the primary clinical business systems utilized for TMF process
- 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
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
- Strong understanding of the primary clinical business systems utilized for TMF processintermediate
- Excellent teamwork, interpersonal, and communication skills, with the 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 teams and to influence areas not under direct control to achieve objectivesintermediate
- Strong analytical and problem-solving skills, with the 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 7+ 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 subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance
- Align with process owners to ensure utilization of clinical business systems is conducted in accordance with established processes and procedures
- Represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements
- Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively
- Provide final business, regulatory, and administrative approvals per applicable SOPs
- Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users
- Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads
- Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews
- Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities
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Sr. Manager, TMF System Business Lead
Bristol-Myers Squibb
Sr. Manager, TMF System Business Lead
Job Description
Provide subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance . Align with process owners to ensure utilization of our clinical business systems is conducted in accordance with established processes and procedures. Align within functional stakeholders to represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements. Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively. Provide final business, regulatory, and administrative approvals per applicable SOPs. Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users. Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads. Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews. Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities. Bachelor's degree in a related field, such as life sciences, computer science, or business administration. Minimum of 7+ years of experience in clinical development operations, with a focus on eTMF. Preference to experience with project management methodologies and tools. Must have a strong understanding of the primary clinical business systems utilized for TMF process. 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.
Key Responsibilities
- Provide subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance
- Align with process owners to ensure utilization of clinical business systems is conducted in accordance with established processes and procedures
- Represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements
- Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively
- Provide final business, regulatory, and administrative approvals per applicable SOPs
- Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users
- Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads
- Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews
- Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities
Required Qualifications
- Bachelor's degree in a related field such as life sciences, computer science, or business administration
- Minimum of 7+ years of experience in clinical development operations with a focus on eTMF
Preferred Qualifications
- Experience with project management methodologies and tools
Skills Required
- Strong understanding of the primary clinical business systems utilized for TMF process
- 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
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
- Strong understanding of the primary clinical business systems utilized for TMF processintermediate
- Excellent teamwork, interpersonal, and communication skills, with the 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 teams and to influence areas not under direct control to achieve objectivesintermediate
- Strong analytical and problem-solving skills, with the 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 7+ 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 subject matter expertise in the utilization of clinical business systems to promote TMF process and regulatory compliance
- Align with process owners to ensure utilization of clinical business systems is conducted in accordance with established processes and procedures
- Represent the end-user needs of TMF to the R&D IT organization including business strategy, business requirements, user testing, and implementation of new systems and enhancements
- Collaborate with cross-functional teams, including global development operations, R&D IT, and vendors, to ensure that TMF processes are conducted efficiently and effectively
- Provide final business, regulatory, and administrative approvals per applicable SOPs
- Actively participate in multiple aspects of User Acceptance Testing including scenario planning, scripting, and coordination with business users
- Create and maintain applicable process and workflow documentation, in collaboration with process owners and process leads
- Serve as a point of contact for compliance related activities including clinical auditing, inspection readiness, preparedness and support, finding assessments, corrective and preventive action development and delivery, and data integrity and audit trails reviews
- Collaborate with R&D IT organization for activities such as active management of super user network, troubleshooting issues across capabilities
Tags & Categories
Answer 10 quick questions to check your fit for Sr. Manager, TMF System Business Lead @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
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